uk denies pfizer’s bid to clear path for biosimilar bevacizumab · 2019-06-25 · 5 aurobindo...

FOR THE LATEST INSIGHT ON GENERICS AND BIOSIMILARS VISIT: GENERICS.PHARMAINTELLIGENCE.INFORMA.COM

INTELLECTUAL PROPERTY

FDA Adds Transparency On Paragraph IVs In Bid To Spur Competition, p.20

MARKET INTELLIGENCE

Volatility Is The New Normal For Industry, p. 6

INTERVIEW

Biogen’s Henshaw Insists Data Is Key In Bolstering Biosimilars, p.12

Issue 405 • 28 June 2019

UK Denies Pfizer’s Bid To Clear Path For Biosimilar BevacizumabAIDAN FRY [email protected]

P fizer has failed to clear the path for launching its Zirabev bevaci-zumab biosimilar in the UK once a

six-month pediatric extension to a sup-plementary protection certificate based on the basic molecule patent protect-ing Roche’s Avastin cancer treatment expires in June next year. While the Ar-row declaration sought by Pfizer – that certain acts would have been obvious in light of the state of the art at a partic-ular date, thus precluding infringement – would “be of real commercial value to Pfizer”, UK Patents Court Judge Mr Jus-tice Birss found that there was “no evi-dence of uncertainty about UK patent

rights” to justify such a declaration.“The true purpose of an Arrow declara-

tion in this case would be for it to be used in foreign courts,” he stated. “I am not per-suaded that that is enough.”

Having obtained a pan-European mar-keting authorization for Zirabev on 14 February this year, Pfizer was looking to clear the path to launching its Avastin alternative in the UK once a six-month pediatric extension to UK SPC GB05/025 expires on 15 June 2020. The SPC is based on a European bevacizumab molecule patent EP1,325,932. Pfizer expects to launch biosimilar bevacizumab in the US and Japan during the fourth quarter of

this year. (Also see “Pfizer Plans For Three Biosimilar Launches In Japan and US This Year” - Generics Bulletin, 3 May, 2019.)

PFIZER TRYING TO CUT THROUGH AVASTIN PATENT THICKET

Roche filed several applications for fol-low-on patents covering breast cancer and ovarian cancer indications in combi-nation with other cancer drugs. The court noted that breast and ovarian cancer accounted for 17% and 15% of bevaci-zumab prescriptions respectively in the top-five European markets.

These secondary patents, which Pfizer described as a “thicket”, include:

• Metastatic breast cancer pat-ent EP2,361,085 and its Fyfe fam-ily, including divisional applications EP2,752,189 and EP3,178,478. The ’085 patent covers combinations of beva-cizumab with chemotherapy agents not approved on Avastin’s summary of product characteristics. Roche has appealed against revocation for ob-viousness of the ‘189 divisional by the European Patent Office, while the ‘478 application is still pending.

• Ovarian cancer patent application EP2,539,367 and its Dupont fam-ily, including divisional application EP3,064,509. The ‘367 application was refused by the EPO, but the ‘509 divisional is pending grant.

• Platinum-resistant ovarian cancer patent EP2,825,558 and its Bernasconi family. The EPO granted the ‘558 pat-ent on 15 May this year, and Roche signalled its intent to file a divisional application covering only combina-tions of bevacizumab with paclitaxel.

However, in each case, Roche de-des-ignated the UK from its European patent applications, moves that Pfizer alleged

CONTINUED ON PAGE 4

2 | Generics Bulletin | 28 June 2019 © Informa UK Ltd 2019

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“This month saw one of the key events on the calendar with the annual

joint conference of Medicines for Europe

and the IGBA”

This month saw one of the key events on the calendar of the generics, biosimilars and value-added medicines industries with the annual joint conference of Medicines for Europe and the International Generic and Biosimilar Medicines As-sociation in Warsaw, Poland.

Delegates observed that these are turbulent times for the off-patent medicines industries, although some found reason to be optimistic despite a host of pressures affecting companies in the sector (p.6).

Data was also presented on the state of the value-added medicines market, with dips in the US and Japan putting a dent in the market despite positive predictions for its future potential (p.16).

We also have the latest coverage from the European Con-gress of Rheumatology, EULAR, where Biogen’s biosimilars chief Ian Henshaw spoke to us about the importance of real-world data in bolstering uptake (p.12)

And in the UK, four firms have been accused by the com-petition regulator of sharing out the market for and sharing information on nortriptyline (p.5), at the same time as the country’s patents court has rejected Pfizer’s attempt to clear a path for launching its Zirabev bevacizumab biosimilar (see front page).

from the [email protected]

genericsbulletin.pharmaintelligence.informa.com 28 June 2019 | Generics Bulletin | 3

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COVER / UK Denies Pfizer’s Bid To Clear Path For Biosimilar Bevacizumab

5 Aurobindo Receives Warning Letter After Form 483

5 Four Accused By UK’s CMA On Nortriptyline

6 Volatility Is The New Normal For Industry

10 Lannett Will Close Cody Site After Failing To Find Buyer

11 German Fund Seeks Security By Choosing Several Suppliers

12 Biogen’s Henshaw Insists Data Is Key In Bolstering Biosimilars

15 Bernie Sanders Urges DoJ To Take Action On Price-Fixing Claims

15 Rogers Becomes Aceto’s President

16 US And Japan Cause A Slip In Value-Added Market

18 Mundipharma And Egis Partner For Pelmeg In Four CEE Markets

18 European Nurses Offered Switching Guide In Eight Languages

19 Celltrion Reports Positive Rheumatoid Arthritis Data From Subcutaneous Infliximab

20 FDA Adds Transparency On Paragraph IVs In Bid To Spur Competition

22 Magellan Rx Pushes For Switching To Oncology Biosimilars

Finnish Agency Backs Bio Substitution But With CaveatsA consultation exercise has convinced Finland’s Fimea medicines agency that pharmacy-level substitution of biologic drugs is viable. But several safeguards and conditions it is proposing could limit the effects of such substitution on uptake.

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Sole US Patent Protecting Apriso Mesalamine Capsules Is ObviousIn a ruling favouring Mylan, GeneriCo and Flat Line Capital, The US Court of Appeals has confirmed an inter partes review finding that key claims of the sole patent listed against Bausch Health’s Apriso mesalamine brand are unpatentable as obvious.

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Green Credentials Should Play Part In Procurement PracticesEnvironmentally friendly practices should be reflected in the procurement practices of European payers, Accord Healthcare’s James Burt believes.

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Sawai’s Upsher-Smith Snaps Up Dr Reddy’s Branded Migraine AssetsUpsher-Smith has acquired US and other territory rights to two specialty product assets of Dr Reddy’s, which appears to be tweaking the commercialization approach of its proprietary products business.

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Amphastar Will Receive $59.9m In Momenta/Sandoz SettlementThe small generics company has talked about using the cash windfall from the expected settlement to fund clinical trials and possibly M&A.

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amounted to “a deliberate and transpar-ent act of shielding”.

NO PROSPECT OF ROCHE GETTING UK PATENTS

“Today, Roche has no relevant UK patent, and furthermore Roche has now aban-doned any prospect of obtaining such a UK patent in future,” Mr Justice Birss stated. “There will never be a Roche UK patent for these indications arising from any of the relevant patent families.”

Noting that the “very substantial” value of the future UK Avastin market for Roche if Pfizer was unable to include all indica-tions on its biosimilar label was “far more than the cost of this sort of litigation”, Mr Justice Birss said: “I infer that Roche’s mo-tive for de-designating the UK is to shield its portfolio from the risk of an adverse decision in this court. There is no other rational explanation.”

As an example of such shielding, he cit-ed the originator’s abortive appeal against revocation of the ‘367 divisional, arguing that “the reason Roche did that was to avoid the risk of an adverse decision on appeal, which would carry more weight than a refusal by the examining division.”

The judge recognized that Roche had “used the ability to file divisionals to main-tain pending applications of as wide a scope as possible”, but stressed that none of this behavior was unlawful. “Objectively this conduct gives rise to significant un-certainty for Roche’s competitors,” he con-ceded. “Roche knows that perfectly well.”

‘SOMETHING MIGHT TURN UP’ FOR ROCHE

“None of this means Roche does not have a bona fide belief that, despite the obvious weakness of its portfolio, it might manage

to get or hold on to some kind of valid patent claim relating to perhaps some of the relevant indications,” Mr Justice Birss maintained. “Something might turn up.”

But while granting an declaration might reduce Pfizer’s pre-launch uncertainty as the biosimilars developer pondered whether to pursue a full label with all indications or a reduced ‘skinny’ label carving out the po-tentially patented uses, the judge found that “given the complete absence of the possibil-ity of UK rights in future, the reality is that the commercial value of an Arrow declaration to Pfizer is the utility it might have in helping Pfizer to defend itself against suits brought by Roche in other European countries.”

DIFFERENT TO UK ADALIMUMAB ARROW DECLARATION

Mr Justice Birss contrasted the present dispute with the UK Court of Appeal’s decision in Fujifilm’s dispute with AbbVie over adalimumab, where Mr Justice Carr had granted an Arrow declaration on the grounds that it would be useful in dispel-ling commercial uncertainty in the light of pending UK divisional applications. “Pfizer does not need the Patents Court to tell it or anyone else that it can freely sell beva-cizumab in this country without risk from the Roche patent families,” he insisted.

Acknowledging that Pfizer intended to import its Zirabev biosimilar into the UK from Belgium, Mr Justice Birss contend-ed that “what Pfizer really wants is a UK judgment so as to use it in Belgium.” But even though a Belgian court were likely

to take such a judgment into account, a UK court was in no better position to rule on the points of patent law at issue.

“What will happen in Belgium is likely

to affect the UK market, but that is only because of the local effect in Belgium of a Belgian designation of the European pat-ent,” he asserted. “It is nothing to do with any UK legal right.”

The judge accepted that when Pfizer first sought an Arrow declaration, Roche had not yet abandoned its UK patent designations, so there should be no accu-sation of “forum shopping” for the most favourable jurisdiction. But given the lack of evidence of any uncertainty over UK patent rights, there was insufficient reason to grant such a declaration, even though it might be useful in promoting a litigation settlement.

In any case, Mr Justice Birss believed, Pfizer had a strong Gillette defense against infringement on the grounds that the claimed combinations were prior art at the time that the patents were granted.

“Given that bevacizumab was an es-tablished agent with a different mecha-nism of action,” he said, “there is an ap-parently strong case that it would be obvious to combine it with the other standard chemotherapy combinations and an apparently strong case that a skilled person would have reasonable prospects of success in providing im-proved efficacy that way.”

Published online 21 June 2019

CONTINUED FROM PAGE 1

“Objectively this conduct gives rise to significant uncertainty for Roche’s competitors. Roche knows that perfectly well” – Mr Justice Birss

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MANUFACTURING

Aurobindo Receives Warning Letter After Form 483AKRITI SETH [email protected]

A urobindo has suffered another compliance blow after receiving a US Food and Drug Administra-

tion warning letter for one of its Indian active pharmaceutical ingredient facili-ties, hot on the heels of its third Form 483 in the span of the last four months for a separate Indian formulations plant.

“The company has received a warning letter dated 20 June 2019 from the FDA relating to our Unit XI API manufacturing facility situated in the Srikakulam district, Andhra Pradesh,” Aurobindo revealed on 21 June. “This action follows the earlier inspec-tion of the site by the FDA in February 2019.”

“We believe the existing business from this facility will not be impacted,” Au-robindo insisted. “We will be engaging with the regulator and are fully commit-ted in resolving this issue at the earliest.” The company maintained that it was “also committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.”

FOLLOWS FORM 483 OBSERVATIONS AT BACHUPALLY

The warning letter comes after the FDA had also recently cited ten observations of good manufacturing practice deficien-cies in a Form 483 aimed at Aurobindo’s

Unit III formulations plant in Bachupally, Telangana, located in South India.

The FDA inspected the plant from 13 May to 24 May and reported a series of quality control issues like incomplete data entered in the laboratory records, lack of assurance that complete and ad-equate cleaning activities were being performed and lack of an adequate data-integrity program.

The agency said there was “no justifica-tion why the firm did not verify incomplete data to perform and adequate assessment of all data available during testing opera-tions.” It further observed that backup data was not assured as secure from alteration, erasure or loss through keeping hardcopy or alternate systems.

“Buildings used in the manufacture, pro-cessing, packing or holding of a drug prod-uct do not have the suitable construction to facilitate cleaning, maintenance and proper operations,” the FDA added.

Responding to the Form 483, Aurobin-do noted that “none of the observations are repetitive and are more procedural in nature.” The firm said it “will be responding to the FDA within the stipulated time,” in-sisting that “the Form 483 will not have an impact on existing business of this facility.”

A previous FDA inspection from 22

February to 1 March had cited 11 obser-vations at Aurobindo’s newly-commis-sioned Unit XVI sterile manufacturing unit, also at Bachupally. Before that, in February 2019 the FDA posted a Form 483 for the Unit IV sterile injectables fa-cility at Aurobindo’s nearby manufactur-ing plant in Pashamylaram that it had inspected two months earlier. That Form 483 contained two observations.

AUROBINDO’S US EXPANSIONFor Aurobindo, the back-to-back FDA ob-stacles come at a time when the company is set to become the second largest gener-ics player in the US by number of prescrip-tions, and the second largest dermatology player in the US, after agreeing to acquire Sandoz’ dermatology and oral solids busi-nesses in a deal worth US$1.0 bn.

Aurobindo’s US sales already make up nearly half of total sales and the company has been doubling-down on the world’s largest drug market with new product launches. The company is also “investing to enhance its foray into complex gener-ics – mainly injectables, ophthalmic, etc. and biosimilars, which will drive its next leg of growth.”


REGULATION

Four Accused By UK’s CMA On NortriptylineDAVID WALLACE [email protected]

K ing Pharmaceuticals and Auden McKenzie “shared out between them the supply of nortriptyline to

a large pharmaceutical wholesaler” in the UK and thus violated anti-competition law, according to accusations leveled at the firms by the country’s Competition and Markets Authority.

“The CMA has provisionally found that, in 2014, the two companies agreed Auden Mckenzie would supply only 10mg nor-triptyline tablets and King would supply only 25mg nortriptyline tablets, as well

as agreeing to fix the quantities and the prices of supply,” the regulator alleges in a statement of objections.

At the same time, the CMA has ac-cused King, along with distributor Alissa Healthcare and wholesaler Lexon, of “exchanging commercially-sensitive in-formation, including information about prices, volumes and entry plans, to try to keep nortriptyline prices high.”

In February this year, Auden Mckenzie was also accused by the CMA of breach-ing competition law by agreeing not to

compete over the supply of hydrocorti-sone tablets to the National Health Ser-vice between July 2011 and April 2015.

Noting that NHS spending on the an-tidepressant nortriptyline “peaked at £38m ($47m) in 2015,” the CMA empha-sized that it had “provisionally found that King and Auden Mckenzie’s conduct, and the subsequent conduct of King, Alissa and Lexon, broke competition law.”

However, the CMA cautioned, “no con-clusion should be drawn that there has been an infringement of competition law



REGULATION

at this stage and the addressees of the statement of objections will now have the opportunity to respond to the allegations.”

“This is the CMA’s provisional find-ing and the companies now have the chance to make representations to the CMA before it reaches a final decision,” the regulator said. This “will be taken by a case decision group, which is separate from the case investigation team and was not involved in the decision to issue the statement of objections.”

ACCORD AND ALISSA RESPONDAccord – which now owns assets of Auden Mckenzie through its acquisition of Actavis UK and Actavis Ireland from Teva in 2017 – insisted that it was “com-mitted to providing effective, affordable healthcare that improves patients’ lives.”

“We are disappointed by the CMA’s de-cision to issue a statement of objections to us,” Accord told Generics Bulletin, “and do not believe Accord UK should be pursued for alleged illegal actions by Auden Mck-enzie simply on the basis that Accord UK subsequently became the owner of some

of the assets related to those actions.” Ac-tavis itself had “acquired Auden Mckenzie on 1 June 2015, after the alleged actions are said to have occurred,” Accord added.

The CMA’s allegations “do not reflect the ownership of the business by Accord UK since they relate to alleged actions by Auden Mckenzie in 2014,” Accord empha-sized. “We intend to defend our position against this provisional finding.”

Meanwhile, a spokesperson for Alissa Healthcare told Generics Bulletin that the firm was awaiting “further discussion with the CMA.”

“For now, it is fair to say that Alissa Healthcare has never entered into any anti-competitive agreement for nortriptyline or any other medicine,” Alissa’s spokesperson said. “We have never disclosed our selling prices to competitors and never disclosed our sales volumes.”

“In 13 years, Alissa has launched a va-riety of cost-effective products that have saved the NHS many millions of pounds, we will continue to do so in the future.”

At the time of writing, King and Lexon

had not responded to Generics Bulletin’s requests for comment on the matter.

NHS ‘PAYING OVER THE ODDS’The CMA’s antitrust director, Geoff Stead-man, said that pharmaceutical compa-nies getting together to restrict competi-tion for the supply of a drug “can lead to the NHS – and ultimately the UK taxpayer – paying over the odds for what are often essential medical treatments.”

“We expect drug suppliers to abide by competition law so that the NHS is not denied the opportunity of benefitting from lower prices for medicines.”

The CMA noted that it had the power to impose a financial penalty on any business found to infringe UK and EU prohibitions of anti-competitive practices “of up to 10% of its annual worldwide group turnover.”

“In calculating financial penalties, the CMA takes into account a number of factors including seriousness of the infringement(s), turnover in the relevant market and any mit-igating or aggravating factors.”


MARKET INTELLIGENCE

Volatility Is The New Normal For IndustryAIDAN FRY [email protected]

The lingering threat of having to make substantial cash pay-outs in US litigation over opioids abuse and

alleged generic price-fixing mean publicly-listed generics players should expect tur-bulent times for their financial valuations and share prices, RBC Capital Markets ana-lyst Randall Stanicky told delegates to the joint annual conference of Medicines for

Europe and the International Generic and Biosimilar Medicines Association.

In an opening session of the confer-ence held in Warsaw, Poland, last week, Stanicky said that “with both opioid and generic price-fixing litigation likely to last for years, per our expert calls, volatility is the new normal for the sector and is like-ly to continue for the foreseeable future.”

Observing that stock performance by biotech firms was down by 4% to date in 2019, and pharmaceuticals companies shares’ were up on average by a mere 3%, Stanicky said this was due in part to the prospect of the opioid and generic price-fixing litigation draining cash reserves, as well as more general fears around drug pricing reform in the US. An initial opioid trial was already underway in Oklahoma “with more to follow”, he noted.

“Healthcare is the worst-performing sector in 2019 year-to-date in both the

“We are starting to see

signs of stability, both

in pricing and margins”

– Randall Stanicky


MARKET INTELLIGENCE

US and world markets,” he pointed out. “This marks a sharp reversal from 2018 when it was the best-performing sector.”

GENERICS EARNINGS EXPECTATIONS CUT BY A QUARTER

Looking specifically at generics players, Stanicky remarked that weaker share pric-es had been justified by financial markets based on earnings pressure. In contrast to overall market growth, generics earnings expectations had been slashed by more than 25% over the past year, with finan-cial guidance provided by firms as they reported annual results in February lead-ing to a sharp rebasing of forecasts.

As many firms saw their US generics operations shrinking in the face of con-solidated buyer power and fierce competi-tion, their non-US businesses were gaining in importance, he noted. However, he felt “this can cut both ways”, due to negative factors such as Japanese generics pricing reforms or the challenges in implementing track-and-trace serialization in Europe.

Nevertheless, Stanicky offered confer-ence delegates some reasons for opti-mism. He suggested that the industry was due a cyclical upswing as the results of re-structuring and portfolio pruning paid off, aided by US approvals of more complex generics and biosimilars. “We are starting to see signs of stability, both in pricing and margins,” he stated, predicting that companies could see improved fortunes as early as the second half of this year.

And while high debt-to-earnings le-verage made major merger and acqui-sition moves difficult, this year might bring some “creative transactions”, he believed. But delivering considerable debt burdens would be “a multi-year process”, he warned.

“Sustainability is the ultimate goal characterized by healthy balance sheets, rational behaviour and efficient regula-tory frameworks,” he concluded.

RISKS TO SUSTAINABILITY ARE REALDuring the same session, IQVIA’s Per Troe-in highlighted the “risk for sustainability” engendered by fierce competition in the biosimilars sector, as well as the risk of shortages, especially for low-volume ge-nerics, being created by increasing pow-er being exerted by buying consortia.

Biosimilars, he pointed out, accounted

for just 7% of total biologics sales in Eu-rope, with sales last year having grown by just over 50% to €4.0bn ($4.5bn), of which Germany contributed nearly €1bn, followed by the UK and Italy. By contrast, biosimilars turnover in France and Spain remained relatively low.

Recent launches of oncology biosimi-lars such as intravenous rituximab and trastuzumab were setting records on up-take, taking around a fifth of the market within two months and maintaining a similar trajectory thereafter, Troein ob-served. “Adalimumab is tracking slower than the latest biosimilars as AbbVie fights back on price,” he added.

While biosimilar etanercept, inflix-imab, rituximab and trastuzumab had all but cornered the market in certain European countries by October last year, Troein said penetration levels varied

widely as many countries failed to fully leverage the savings potential.

The variable uptake of biosimilars in Europe was, he said, coinciding with a slowdown in volume growth for small-molecule generics, as the market expand-ed by only about 2% last year to almost 250bn standard units. But with Europe’s non-generics sector in reverse, generics’ share of the overall 420.9bn units market rose by a percentage point to 59%.

On a global scale, Troein said the total generics market was approaching 1.6tn units, but was fragmenting. “Market shares of large multisource generic com-panies have declined,” he stated, with Te-va’s volume share having dipped below 5%, and Sandoz’ just below 4%. Mylan, Sanofi and Cipla were, he said, fighting it out for third place, with each on a little over 2% of the global market.

“In value terms,” Troein observed, “the top-10 generics companies hold less market share than six years ago.” Having controlled nearly a third of the market measured in local-currency dollars in 2012, the top-10 players’ combined hold had fallen to 24.1% as of the 12 months ended June 2018. “Large companies have exited unattractive products and markets,” he noted.

Citing IQVIA data for the world’s top-10 markets by volume last year, Mylan’s head of global policy, Marcie McClintic

Generics Take Three-Fifths Of European Market, ButVolume Growth Has Slowed

From volume growth of about 6% earlier in the decade, the rise in generics sales measured in standardunits had slowed to around 2% by 2018, data from IQVIA shows.

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%2012 2013 2014 2015 2016 2017 2018

Generics Non-Generics Other

Shares of the European prescription pharma market, measured in standard units (Source - IQVIA)

Generics Take Three-Fifths Of European Market, But Volume Growth Has Slowed

From volume growth of about 6% earlier in the decade, the rise in generics sales measured in standard units had slowed to around 2% by 2018, data from IQVIA shows.

Shares of the European prescription pharma market, measured in standard units (Source - IQVIA)

“Adalimumab is

tracking slower than

the latest biosimilars

as AbbVie fights back

on price” – Per Troein



MARKET INTELLIGENCE

Coates, said generics filled 60% of pre-scriptions for less than one fifth of pre-scription spending that totalled $709bn.

MULTIPLE PRESSURES THREATEN ACCESS AND SAVINGS

But even as it provided access at low cost, the industry was facing multiple pres-sures that were “threatening patient ac-cess and future savings.”

Around the world, industry players were coming under intensive pricing pressure due to factors including: the greater power of purchasers and pricing bodies in negotiations; increased compe-tition through more approvals and new entrants; “misguided policies that limit the ability to respond to market dynam-ics”; and less uptake for new launches, especially specialty generics and biosimi-lars, due to rebates and formulary tactics, as well as supply-chain consolidation.

At the same time, McClintic Coates outlined, companies were facing rising operating costs as they had to step up investments in more complex pipelines and manufacturing systems requiring greater volumes at ever stricter quality standards. Regulatory requirements in general were, she said, increasing and frequently inconsistent, while patent abuse was delaying patient access to more affordable medicines.

“As a result, supply disruptions are felt by patients around the world,” she warned.

Voicing a global call to action, McClint-ic Coates set out six guiding principles for policymakers to ensure a “viable generics and biosimilars market for patients”:

• Value delivered by generic and bio-similar manufacturers should be rec-

ognized in pricing and reimbursement• Incentives should be advanced that

favour and sustain generics and biosimilars throughout the health-care system

• Abuses that delay launches of more affordable medicine through trade or patent policy must be reversed

• Ban brand tactics that delay generic or biosimilar competition

• Leverage science to harmonize and rationalize regulatory requirements and advance complex approvals

• Educate patients, providers, phar-macies, payors and public about the safety and efficacy of generics and biosimilars

Zentiva CEO Nick Haggar insisted he was “really positive about our industry, because we have had for many years the patient at the centre of what we do.” “We provide medicines for the many, not the few, so I think our voice is strong and what we say is highly legitimate to the patient,” he asserted.

Investors, he recognized, required “logical, rational investment and a fair

return” in exchange for funding. “My own company, Zentiva, is an indication that there is a positive sense of the val-ue of the industry and the role that we play, having recently been acquired,” he commented.

The biosimilar investment cycle over the past decade or two had been “a mas-sive undertaking for our industry”, he noted. “It is clear that, as of today, it re-mains unproven,” he admitted.

GENERICS AND BIOSIMILARS INDUSTRY CANNOT BRIDGE GAP ALONE

Haggar insisted that policymakers need-ed to support the business case for such investments that provided patient ac-cess. “I don’t think the generics and bio-similars industry can alone bridge the gap between industrial procurement policies of insurers or governments and the need to maintain continuous supply of low-cost, high-quality medicines.”

Returning to Stanicky’s comments around sustainability, Haggar insisted that a balance needed to be struck. “We should take our energy, our conversa-tions, our perspectives and the huge contributions we make to public health back to the policymakers and insurers,” he advised. Bringing in the patient’s voice would, he argued, be crucial in highlight-ing the true value of medicines.

“It is on us,” Haggar concluded. “We sometimes come here each year with a certain cloud of depression that can sink over us,” he recognized. But while the chal-lenges were real, so was the industry’s ability to meet them. “I am in the optimists’ camp,” he stated.


“We provide medicines for the many, not the

few, so I think our voice is strong and what we say is highly legitimate

to the patient” – Nick Haggar

Visit https://pharmaintelligence.informa.com/generics-bulletin

Unrivalled coverage, news and analysis of the global generics, biosimilars and value-added medicines industries


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STRATEGY

Lannett Will Close Cody Site After Failing To Find BuyerAIDAN FRY [email protected]

L annett intends to shut down its Cody Laboratories active pharma-ceutical ingredients operation by

the end of September, shedding 70 jobs, after failing to find a buyer for the busi-ness. The move forms part of the US ge-nerics specialist’s restructuring plan in the wave of losing a supply contract for its best-selling drug, levothyroxine.

Soon after it lost the levothyroxine dis-tribution contract with Jerome Stevens Pharmaceuticals, Lannett said last year it was looking to divest its Cody Labs APIs business based in Cody, Wyoming.

The site, which Lannett acquired in 2007, specializes in particular in opioid-based controlled substances such as hydrocodone, hydromorphone, methyl-phenidate and morphine sulfate, while its current pipeline includes lisdexamfe-tamine dimesylate. Since last year, it has been led by its president, former Teva executive John Abt.

“The company has been unable to sell the Cody API business as an ongoing operation and now intends to sell the equipment and real estate utilized by the Cody API business and to have Cody Labs cease all operations,” Lannett revealed in a filing with the US Securities and Ex-change Commission.

CUTTING REMAINING 70 JOBS AT CODY SITE

As part of its ‘Cody API restructuring plan’, which the firm expects to be “substantial-ly complete” by 30 September, Lannett plans to eliminate all remaining 70 posi-tions at Cody Labs.

Associated restructuring costs are currently estimated at about $5.0m, comprising $2.5m of severance and em-ployee-related costs, $2.0m of contract-termination expenses and $0.5m of costs connected with moving equipment and other property to other facilities owned by the company.

Beyond those restructuring costs, Lannett expects to incur an impairment charge relating to the facility, equipment and other assets “of up to $6m.” The com-pany stressed that the non-cash charge,

which comes on top of a $29.9m impair-ment hit taken when it approved a plan to sell Cody last year, would not impact its leverage ratios for debt covenants.

BROAD DRIVE TO REDUCE OPERATING EXPENSES

Restructuring and divesting Cody formed part of a broader cost-cutting program that Lannett unveiled late last year with a view to shaving around $66m from an-nual operating expenses.

The legacy of the Jerome Stevens deal

resulted in thyroid deficiency drugs, es-sentially levothyroxine, accounting for well over a third of Lannett’s group turn-over of $521.6m in the nine months end-ed 31 March 2019.

With its cost-reduction program now “nearly complete”, Lannett is focusing on bolstering its post-levothyroxine portfolio and replenishing its pipeline. As part of its efforts to add around $75m of new product revenues annually, the US company recently started marketing amphetamine salt immediate-release

Lannett Working To Replace Lost Levothyroxine SalesUS generics specialist Lannett is looking to bolster its portfolio with $75m per year of new productsales as it looks to replace revenues lost when a supply deal ended for the thyroid deciency drug levothyroxine

Nine-Month Sales $521.6m


197.6

70.245.5

36.8

171.4

Thyroid deciency

Cardiovascular

Antipsychotics

Gastrointestinal

Other

Three-Month Sales $172.8m


55.2

22.8

20.6

11.7

62.5

Thyroid deciency

Cardiovascular

Antipsychotics

Gastrointestinal

Other

Lannett's sales in the nine and three months ended 31 March 2019 (Source - Lannett)

Lannett Working To Replace Lost Levothyroxine SalesUS generics specialist Lannett is looking to bolster its portfolio with $75m per year of new productsales as it looks to replace revenues lost when a supply deal ended for the thyroid deciency drug levothyroxine



197.6

70.245.5

36.8

171.4

Thyroid deciency

Cardiovascular

Antipsychotics

Gastrointestinal

Other



55.2

22.8

20.6

11.7

62.5

Thyroid deciency

Cardiovascular

Antipsychotics

Gastrointestinal

Other

Lannett's sales in the nine and three months ended 31 March 2019 (Source - Lannett)

Lannett Working To Replace Lost Levothyroxine Sales

US generics specialist Lannett is looking to bolster its portfolio with $75m per year of new prod-uct sales as it looks to replace revenues lost when a supply deal ended for the thyroid deficiency drug levothyroxine

Lannett’s sales in the nine and three months ended 31 March 2019 (Source - Lannett)


STRATEGY / PRICING

tablets equivalent to Adderall and also introduced several strengths of generic Concerta (methylphenidate) extended-release tablets.

Having recently started a clinical trial for an insulin glargine biosimilar it is developing with partner HEC for the US market, Lannett has also just expanded its cardiovascular offering by launching internally-developed aspirin/dipyridam-ole extended-release capsules equiva-lent to Boehringer Ingelheim’s Aggrenox antiplatelet agent.


“The company has

been unable to sell

the Cody API business

as an ongoing

operation and now

intends to sell the

equipment and

real estate utilized

by the Cody API

business and to have

Cody Labs cease all

operations” – Lannett

The Pharma Pricing Info That

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To find out more... call +44 1702 425125 or email [email protected].

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German Fund Seeks Security By Choosing Several SuppliersAIDAN FRY [email protected]

G erman health insurance fund Barmer is seeking to mitigate the risk of supply disruptions

by handing contracts for four-fifths of the 169 bidding lots in its 12th medi-cines tender to more than one sup-plier. However, the key criterion for selection as a supplier remains price.

By electing to seek up to three sup-pliers for 136 of the 169 lots in the tender running for two years from 1 October 2019, Barmer has taken a distinctly different approach to that of its rival fund, AOK, which recently handed out just 19 of 118 bidding lots in its latest tender round on a non-ex-clusive basis.

“When choosing our rebate part-ners,” Barmer chairman Mani Rafii explained, “we consider not only eco-nomics but also the consistent provi-sion of medicines to our members. By having several products from which to choose, we can offer alternative modes of provision and prevent sup-ply shortages.”

Barmer’s 12th tender round, which will replace deals under its 10th round that expires on 30 September this year, covers 154 active ingredients or combinations with total annual sales of around €1.1bn ($1.2bn). Among the broad range of ingredients included in the tender are commonly-used analgesics, anti-infectives, cardiovascular drugs and medicines for metabolic conditions.

EXCLUSIVE SUPPLY DEALS FOR 33 BIDDING LOTSThe fund has given exclusive supply deals for 33 lots, but was unable to find a suitable supplier for another nine lots.

In total, Barmer now has tender supply deals in place for around 280 off-patent mol-ecules that have combined annual sales of about €1.9bn.

German off-patent medicines industry association Pro Generika has consistently ar-gued that awarding tender contracts to multiple suppliers per molecule is a key tool in tackling drug shortages. However, its arguments went unheeded by the country’s Bundestag lower house of parliament as it passed multi-faceted legislation aimed at improving medicines provision that did not require funds to change their procurement practices by eschewing exclusive contracts.

Describing as a “blunt sword” the legislation that will come into effect at the start of July if passed by the country’s Bundesrat upper house, Pro Generika said it “changes nothing on the dangers of medicines shortages.”


“By having several products from which

to choose, we can offer alternative modes of

provision and prevent supply shortages” -

Mani Rafii



INTERVIEW

Biogen’s Henshaw Insists Data Is Key In Bolstering BiosimilarsDAVID WALLACE [email protected]

A round €1.8bn ($2.02bn) in European healthcare cost savings are expected in 2019 from uptake of Biogen’s anti-TNF biosimilars portfolio of Benepali (etanercept),

Flixabi (infliximab) and Imraldi (adalimumab), according to the latest figures revealed by the firm at the European Congress of Rheumatology, EULAR.

At the same time, the firm has released a series of nine ab-stracts detailing real-world data from the biosimilars portfo-lio developed through its Samsung Bioepis joint venture with Samsung BioLogics.

Based on “open-ended questions about treatment experi-ence”, the data “provide further insight into patient experi-ence with anti-TNF biosimilars, including adherence data,” the firm outlined.

Data presented included results of the ‘Benefit’ study, which evaluated the outcomes of transitioning from the Enbrel etaner-cept reference brand to its biosimilar in routine clinical practice. “The study demonstrated no clinically significant difference in disease score from baseline to six months post-transition in 533 patients suffering from rheumatoid arthritis and axial spondylo-arthritis,” Biogen reported.

Separately, data was presented from “a pooled analysis of etanercept, infliximab and adalimumab biosimilars and refer-ence products across 1,461 patients.” This “demonstrated similar outcomes between biosimilars and their respective reference products in terms of disease fluctuation at six months and one year of treatment.”

DATA SUPPORT KEY PATIENT REGISTRIESIn an exclusive interview with Generics Bulletin, Biogen vice-president and head of the firm’s global biosimilars business unit, Ian Henshaw, said Biogen’s real-world evidence was “very important” in terms of supporting “key patient registries” of data. Biogen and Samsung Bioepis were supporting around 20 patient registries across Europe – pooling around 25,000 pa-tients – as part of efforts to confirm the safety and tolerability of biosimilars, he noted.

“People have questions,” Henshaw acknowledged, with such registries able to address open questions, particularly on the pa-tient side but also from prescribers. “Attitudes are continuing to evolve towards much more confidence from patients and pre-scribers,” he indicated.

With the biosimilars market still being relatively young, Hen-shaw suggested, molecule-specific data would continue to be important, with real-world data playing an vital role for classes such as anti-TNF and oncology biosimilars.

PRICE AND UPTAKE LEAD TO SAVINGSWhen questioned on whether the savings potential offered by biosimilars could be as important as, or even more important

than, data in convincing stakeholders to put efforts into driving uptake, Henshaw conceded that “it could be as simple as that,” but that in general “it’s both.”

“Savings are important, but data really matters,” he main-tained, pointing to discussions taking place at EULAR around the quality of data, the quality of individual products and optimum treatment regimes. “There’s a better economic ar-gument now,” he said, “and real-world data, plus confidence around patient pathways.”

Asked about whether the high savings levels seen in Europe were more due to uptake or price discounting, Henshaw com-mented that “the great thing about Europe is that you have the full spectrum”, pointing to early price cuts and immediate adoption in the Nordics, compared to larger countries and es-tablished healthcare systems where the relationship between patients and pharmacists on biosimilars was still being clarified. “So it’s both,” Henshaw acknowledged.

Biogen could boast “an incredible story” with its biosimi-lars savings, Henshaw insisted, with its €1.8bn total across the three products representing savings that could then give payers headroom for innovation, as well as improved quality of care and greater access in terms of the number of patients being treated.

With Biogen contributing “roughly half” of the estimated €3.85bn total European savings across all anti-TNF biosimilar providers, Henshaw said the firm was exceeding even its own earlier estimates. “We went back and checked previous calcula-tions,” he noted – such as the €800m annual savings estimate for Benepali cited by the company a year ago – “and we actually did a little bit more.”

Biogen was also working on improvements to set its biosimi-lars apart from other competitors, Henshaw said, citing “stability out of the fridge” as an example of an area where the firm could offer an advantage over rivals.


INTERVIEW

MULTIPLE ADALIMUMAB LAUNCHES COULD BE A FUTURE MODEL

Looking back on the launch of multiple European adalim-umab biosimilars in October – leading to deep discounts that have seen major markets make significant savings over Hu-mira – Henshaw acknowledged that multiple competitors be-ing ready on ‘day one’ would be a reality for certain biosimilar launches in future.

“Looking at the development programs of every single ma-jor monoclonal antibody in the next ten years, there is certainly going to be more than one developer coming to market,” he pointed out. “Price competition will be a key factor,” he stated, and “deep discounts with a number of competitors hitting the market at the same time will be a future model.”

For this reason, he said, it was key to place an emphasis on dif-ferentiation, whether in terms of service or at the product level.

Adalimumab was somewhat unique in being the biosimilar of “the most successful drug in the world,” Humira, Henshaw said, and thus attracted a very high level of competition. But regard-less, he maintained, in Europe it was clearly very important to be there from day one, and equally important for a provider to ensure that it did not run out of supply.

“We were launch ready, from day one, and had two other anti-TNFs in the marketplace,” Henshaw elaborated, thus allowing Biogen to build on existing customer relationships and take a lead in the adalimumab market.

“That whole suite is helping us to be leading in the market-place,” he explained, “and with that comes volume of patients. We are serving around 145,000 patients, and that will continue to grow as markets adopt more biosimilar uptake.”

LESSONS FOR US CAN BE LEARNED IN EUROPETurning towards Biogen’s ambitions in the US market, Henshaw said that despite the European market being composed of many diverse healthcare systems compared to the US, “we can look to Europe for inspiration.”

“We can look to Europe for how to educate patients, patient groups, nurses and physicians,” he said, “and we can inspire US healthcare systems with the cost savings that they can use to expand access or simply make as a saving.”

“America is at the start of its journey,” Henshaw elaborated. “The US Food and Drug Administration is making very good progress on biosimilars and how they will approve and legis-late around biosimilars,” while “industry must make sure that there is a balanced approach going forward with biosimilars and innovation in the US” to meet the terms of what he called the “social contract around savings and innovation.”

RISK OF ‘WINNER TAKES ALL’ APPROACHAsked about Biogen’s future plans, and whether the firm would continue to focus on the larger opportunities in biosimilars, Henshaw acknowledged that “deep pockets are required to bring a biosimilar to the marketplace,” meaning that maximizing the value of investments was important.

“We’re seeing that the US will have 50% of biologics coming off-patent in the short-term,” he observed, and up to 70% when projecting out further. “But also China, the far East, Japan are fac-

ing the same situation. If your development can include world-wide assets, that’s important.”

“The key point is the question of sustainability,” Henshaw contended. “It’s well-voiced, but poorly understood. In order for [the biosimilars model] to work, there needs to be stabil-ity about tendering, contracts, pricing.” While ‘winner-takes-all’ procurement models were “good for the winners”, they were not good for other players, he warned, meaning some provid-ers may see such opportunities as too risky and pull back from being in the initial wave.

“We are already seeing this happen,” he observed, “with Boehringer not launching [its adalimumab] in Europe, and with Coherus not launching [its pegfilgrastim] in Europe.”

While there were still questions to resolve around substitu-tion and interchangeability of biosimilars, Henshaw said it was important to always bring it back to the question of patients and unmet needs.

“We are advancing and leading in the science – biosimilar-to-biosimilar switching is the [current] big debate – and go-ing forward we have a commitment around that,” he offered, adding that there were also ongoing discussions around issues such as stability and device preference. “But,” he concluded, “I want to bring it back to dealing with patients’ unmet needs, making sure the physician is involved, and making sure the pa-tient is on that journey.”


Ian Henshaw

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BUSINESS STRATEGY


Do you havemoney to burn?Your old NDAs and ANDAs are VALUABLE ASSETS and withdrawing them from theOrange Bookis like BURNING MONEY.

Don’t make the same mistake other owners have already made!For more information: [email protected]

No matter the condition of your A/NDA, it should never be withdrawn

from the Orange Book.We will make you a cash offer, regardless

of the condition or age of your file.

Remember: Once approval of your A/NDA is withdrawn,

there is no way to bring it back!


REGULATION

Do you havemoney to burn?Your old NDAs and ANDAs are VALUABLE ASSETS and withdrawing them from theOrange Bookis like BURNING MONEY.

Don’t make the same mistake other owners have already made!For more information: [email protected]

No matter the condition of your A/NDA, it should never be withdrawn

from the Orange Book.We will make you a cash offer, regardless

of the condition or age of your file.

Remember: Once approval of your A/NDA is withdrawn,

there is no way to bring it back!

Bernie Sanders Urges DoJ To Take Action On Price-Fixing ClaimsAKRITI SETH [email protected]

U S Senator and 2020 Presidential hopeful Bernie Sanders, along with Rep. Elijah E Cummings,

have written to the Department of Jus-tice (DoJ), urging it to “prioritize criminal enforcement of federal antitrust laws against generic drug manufacturers.”

In May 2019, a coalition of 44 US states attorneys general sued 20 generic drug manufacturers and more than a dozen executives for engaging in a multi-year, multi-billion-dollar price-fixing conspir-acy. This list of companies included big names like Teva, Mylan, Pfizer and Sandoz.

In these civil proceedings, the manufac-turers are accused of “a broad conspiracy to artificially inflate and manipulate pric-es, reduce competition and unreasonably restrain trade for more than 100 different generic drugs.”

Teva was identified as “a consistent par-ticipant in the conspiracies” and accused of “participating in a wide-ranging series of restraints with more than a dozen ge-neric drug manufacturers, all of whom knowingly and willingly participated.”

Encouraging criminal enforcement

over civil enforcement, Sanders and Cum-mings’ letter says, “if these allegations are true, civil enforcement will not be suffi-cient to protect consumers or businesses that compete fairly, maintain the integrity of our economic system, or deter anti-competitive conduct in the future.”

Since approximately 90% of all prescrip-tions filled in the US are for generic drugs, Sanders and Cummings are of the view that, “vigorous antitrust enforcement is vi-tal to ensuring that millions of Americans can afford the medications they need.”

The letter further requests a briefing by 21 June 2019 from the DoJ “about the ac-tions it is taking to protect patients and taxpayers from anti-competitive conduct by the generic drug industry.”

CRIMINAL PENALTY FOR HERITAGERecently, Heritage Pharmaceuticals en-tered into a deferred prosecution agree-ment resolving a one-count felony charge, under which it paid a $225,000 criminal penalty and agreed to cooperate with the DoJ’s criminal investigation of other ge-neric drug manufacturers.

Calling the amount of the criminal penal-ty “wholly insufficient to deter future crimi-nal conduct by Heritage or other generic manufacturers,” Sanders and Cummings point out that the DoJ “has not announced any charges against additional generic manufacturers or executives” since then.”

Heritage also paid $7.1m to resolve alle-gations under the False Claims Act that it en-gaged in a price-fixing conspiracy. However, the company clarified that the settlement deal with the DoJ over price-fixing allega-tions did not include entering a guilty plea.

The letter also asks the DoJ to open an investigation into whether Teva and its co-conspirators obstructed a 2014 inves-tigation into their business practices.

Accusing Teva of misleading the inves-tigation by not complying document and information requests, Sanders and Cum-mings claim that the “excuses” made by Teva such as “costs of regulatory compli-ance, drug shortages and user fees” were” at best grossly misleading and at worst, false statements to Congress.”


APPOINTMENTS

Rogers Becomes Aceto’s PresidentDAVID WALLACE [email protected]

A ceto has promoted its chief legal officer, Steven Rogers, to become president of the struggling US

firm as it navigates its way through bank-ruptcy proceedings and divestments of its Rising Pharmaceuticals generics unit and chemicals business.

The move comes shortly after the firm announced that it “no longer requires” William Kennally as president and CEO, terminating his tenure from the end of May but retaining him as a director.

Aceto is continuing to work its way through bankruptcy proceedings that have included deals to divest a significant por-tion of its business. The company recently

completed the sale of its Rising Pharma-ceuticals generics unit – along with Rising’s subsidiaries and related assets – to Shore Suven Pharma for $15m, as well as firming up plans to sell its chemicals business to an affiliate of New Mountain Capital.

Meanwhile, the Nasdaq stock exchange has delisted the firm, which is now trading on the OTC Pink Market. “The transition does not affect the company’s operations,” Aceto insisted, “and does not change re-porting requirements under SEC rules.”

ROOF DEPARTS CFO ROLEAt the same time as announcing Rogers as president, Aceto revealed that Rebec-

ca Roof had stepped down as chief finan-cial officer, having served in that capacity since April 2018.

“As a managing director of AlixPartners LLP, Roof will – together with AP Services LLC, an affiliate of AlixPartners – continue to provide financial and restructuring advice to Aceto through the pendency of Aceto’s bankruptcy proceedings,” the firm stated.

Roof will be succeeded as CFO by Car-rianne Basler, subject to bankruptcy court approval. Basler, 50, is also a managing director of AlixPartners and “has held nu-merous interim management, consulting and advisory positions with AlixPartners for more than 23 years”, having served on a team providing services to Aceto since February this year.




VALUE-ADDED MEDICINES

US And Japan Cause A Slip In Value-Added MarketAIDAN FRY [email protected]

G lobal sales of value-added medi-cines slipped slightly to $43bn in the 12 months ended March

2019 as US pricing controls and lower de-mand in Japan for analgesics and mental health drugs took their toll.

Presenting data on the market for value-added medicines – defined as off-patent, branded non-biological drugs that have not been launched or licensed by the mol-ecule’s originator and offer some form of additional value over a standard generic – during the joint annual conference of Medicines for Europe and the International Generic and Biosimilar Medicines Associa-tion, IQVIA senior consultant Aurelio Arias said value-added medicines currently con-tributed around 4% of the global $1.1tn pharma market, measured at list prices.

“The decline in sales is due to some iso-lated cases,” Arias explained. “Our largest market, the US, has been going, and con-tinues to go, through some pricing controls on some large products. And in Japan, we have seen a decrease in medicine usage, especially in the big therapy areas for value-added medicines – pain and mental health.”

Noting that IQVIA’s definition of value-added medicines now encompassed all products that had gone through the hybrid 505(b)(2) regulatory pathway in the US, Arias observed that the US accounted for seven-tenths of the global $43bn market. But while the US had shown low- to mid-single-digit growth over the past five years, value-added sales had slipped slightly in the 12 months ended March 2019.

European value-added sales amounting to around $5.6bn following low-single-digit growth contributed 13% to the global total. “A big driver of European growth has been the respiratory side,” Arias commented.

By far the strongest rise in sales of value-added medicines over the past 12 months and five years has been seen in emerging or BRICTM – Brazil, Russia, India, China, Turkey and Mexico – mar-kets, where turnover has advanced con-sistently at about 15% per year. “These countries are leading in terms of their ability to adopt medicines,” he remarked, referencing “high growth in the oncology

and diabetes spheres” in China.Looking at the value-added market by

therapy area, Arias pointed out that the fastest-growing categories often affected the central nervous system, such as epilep-sy, Parkinson’s disease and attention deficit hyperactivity disorder (ADHD) therapies. “The reason why we have mental health and CNS products in the fastest-growing sectors is because it is a misunderstood therapy area with very old medicines that are not fit for many of the patients out there with these conditions,” he elucidated.

ADDING VALUE BY MAKING MEDICINES EASIER TO TAKE

“Some of the patients are unable to take their own medicines through no fault of their own,” Arias continued. “It is here that value-added medicines are really able to add a compelling advantage for the pa-tient, and at times also for the physician.”

Certain cardiovascular drugs, such as epinephrine autoinjectors like Kaleo’s Au-vi-Q in the US, were also driving growth in the value-added arena, he said, add-ing that other product classes such as sex hormones were on the decline in the US.

On a global basis, combination thera-pies account for just over a quarter of to-tal value-added drug sales.

In terms of the routes of administra-tion, Arias noted that oral formulations still led the way, but they no longer con-

stituted half the market as parenteral in-jectables became more prevalent amid a general market shift towards specialty medicines. Over the past five years, val-ue-added injectables have shown a 15% compound annual growth rate, led by a 24% advance in sales of pre-filled syring-es as turnover from infusions and vials showed a five-year CAGR of around 10%.

“A key story here is that injectables are a big growth area, not only for value-added medicines,” he said, adding that

the sector was increasingly of interest to logistics, contract-manufacturing and packaging suppliers. “They see that in-jectable markets are where the future lies for their clients. They are looking, for example, at how they can add value to packaging to have a synergy with value-added medicines.”

This trend, Arias believed, was set to continue as oncology treatments increas-ingly gained traction in emerging markets.

By contrast, the five-year CAGR to March 2019 for value-added tablets, gels and creams was negative.

Arias observed that Europe had histori-cally lagged behind the US in terms of the number of value-added medicines ap-proved each year. While the US 505(b)(2) route included provisions for three years of exclusivity, there was no data exclusiv-ity written into Europe’s corresponding Article 10(3) regulatory pathway.

“The US is leading the charge, and we have to understand how to get Europe to similar levels of approvals,” he commented.

Looking towards the future, Arias re-vealed that IQVIA’s thought leadership team, of which he is a member, was work-ing on a white paper that should be pub-lished “within the next few weeks.”

“We firmly believe value-added medi-cines are going to be helped out by the dig-ital aspect,” he told conference delegates. Recognizing the difficulty of pinpointing

the sector and communicating the value to stakeholders of incremental improvements along a spectrum of innovation, Arias said most companies could play somewhere in a range running from continuous innova-tions based on existing technologies, such as new combinations and formulations, through to breakthrough innovations driv-en by cutting-edge technologies such as nanoparticles.

“If you look at what is going to be hap-pening over the next five to 10 years in

“There is not one set of data that is standard for each innovation – you have to differentiate between various types of added value” – Francis Arickx


VALUE-ADDED MEDICINES

digital,” he predicted, “we are going to start to get interconnected devices through the internet of things.” Rapidly falling costs of sensors and computational power were starting to come into the pharma industry and would “touch the whole of the value-added medicines sector.”

As examples, he cited medical applica-tions that were being approved by regu-latory bodies for integration with smart devices such as phones and watches. San-doz’ collaboration with Pear Therapeutics around digital therapeutics for substance abuse did not depend on an off-patent drug, but could be used in conjunction with generic drugs to improve adherence and inform physicians how the therapy was performing, he pointed out.

THREE KEY MILESTONES ON DIGITAL JOURNEY

“There are three key milestones in the evolution of digital integration,” Arias con-tended. The first, he said, was data capture through smaller sensors and better con-nectivity for delivery devices such as in-halers and mini-pumps that could gather data points and track patient usage. As a second stage, such data could be used to derive deeper insights into patient behav-iour and prescribing decisions through analytics and algorithms, which in turn would support communicating value to stakeholders through real-world data.

The third step, which would be “a quan-tum leap, more on the 10-year horizon”, would be gamification. “Once you get to the point where you are able to under-stand the behaviour of your patients,” he wondered, “can you then incentivize their behaviour in positive ways by having de-vices respond back to the patients?”

Acknowledging the coming wave of digital therapeutics, Francis Arickx – head of the directorate for reimbursement of medicines and pharmaceutical policy at Belgium’s national health insurance body RIZIV-INAMI – warned that it would be dif-ficult for payers and health technology as-sessment bodies to ascribe value to them. “I am not convinced that a lot of countries are ready for them,” he stated.

National systems were poorly prepared for such digital innovations, Arickx be-lieved. Patient expectations were likely to be high, he felt, but the level of expertise available to funding bodies was unlikely

to keep pace. “We are going to hit the ceil-ing at some point and have to confront reality,” he cautioned. Within Europe, more affluent nations in the north-west corner of the continent would probably lead the way, he believed, questioning whether such questions needed to be addressed at a pan-European level.

BELGIUM CREATED SEPARATE P&R PATHWAYS

Outlining how Belgium had created dedi-cated pricing and reimbursement proce-dures for value-added medicines and bio-similars, separate to those for novel drugs and generics, Arickx insisted that HTA as-sessments should not be viewed as stand-

alone academic exercises, but rather must “serve a purpose” in guiding clinical practice.

“There is not one set of data that is stan-dard for each innovation – you have to dif-ferentiate between various types of added value,” he maintained. “In a lot of cases,” he argued, “pure common sense is useful.”

“If you have a pre-filled syringe versus a vial, you do not need hard endpoints on progression-free survival,” Arickx asserted. “If you look at how personalized medi-cines, gene therapies and orphan drugs are treated by HTA bodies, we already use different sets of evidence, so why can we not do that for value-added medicines?”


Global Value-Added Medicines Market Stalls At $43bnSlowing sales in the US and Japan caused the global value-added medicines market to stagnate at$43bn in local-currency dollars in the 12 months ended March 2019, according to IQVIA data

MAT Q1 2019 Sales (local-currency) $43bn

70%

13%

8%

4%6% US

Europe

Japan

BRICTM

Rest of World

Global sales of value-added medicines by region in the 12 months ended 31 March 2019 (Source - IQVIA)

Global Value-Added Medicines Market Stalls At $43bn

Slowing sales in the US and Japan caused the global value-added medicines market to stagnate at $43bn in local-currency dollars in the 12 months ended March 2019, according to IQVIA data

Global sales of value-added medicines by region in the 12 months ended 31 March 2019 (Source - IQVIA)

Injectables Is The Fastest-Growing Administration Route ForValue-Added Medicines Due To A Shift To Specialized Medicines

Parenteral Injectables Have Shown A Five-Year Compound Annual Growth Rate Of 14%

26%

18%

21%

9%

7%

5%

15%

Oral IR

Oral Long-Acting

Parenteral

Topical

Lung

Uterine

Other

Global value-added medicines sales by administration route in the 12 months ended 31 March 2019 (Source - IQVIA)

Injectables Is The Fastest-Growing Administration Route For Value-Added Medicines Due To A Shift To Specialized Medicines

Parenteral Injectables Have Shown A Five-Year Compound Annual Growth Rate Of 14%

Global value-added medicines sales by administration route in the 12 months ended 31 March 2019 (Source - IQVIA)



DEALS

Mundipharma And Egis Partner For Pelmeg In Four CEE MarketsAKRITI SETH [email protected]

Mundipharma has entered into a distribution partnership with Egis Pharmaceuticals for its Pelmeg (pegfilgrastim) biosimilar. The agreement covers countries in central and

eastern Europe (CEE) where Mundipharma does not have a direct commercial presence: Hungary, Romania, Latvia and Lithuania.

“Egis is one of the leading branded generic companies in the CEE and Commonwealth of Independent States (CIS) regions,” Mundipharma noted, “belonging to Servier Group, with a strong presence in the biosimilars market.”

According to Mundipharma, this exclusive outsourcing distribu-tion deal is likely to “expand patient access to their pegfilgrastim treatment to reduce the duration of chemotherapy-induced neu-tropenia and the incidence of febrile neutropenia in adult patients.”

Egis CEO Istvan Hodasz commented, “Egis is looking forward to expanding its three-drug biosimilar monoclonal antibody port-folio with Pelmeg in CEE. We are highly committed to improve

patient access to affordable, high-end therapeutic options in CEE and CIS countries.”

While Egis will oversee the launch and distribution of Pelmeg in the CEE, Mundipharma will be responsible for the direct launch of Pelmeg in most of its other European markets.

Commenting on this alliance with Egis, Alberto Martinez, CEO of Mundipharma in Europe said, “our long-term partnership demonstrates our determination to move medicine forward and will expand the reach of this much needed treatment and con-tribute to reducing healthcare costs in the region.”

MUNDIPHARMA’S EXPANSION IN THE EUPelmeg is the fourth biosimilar medicine to be commercialised by the Mundipharma network. It was developed by Cinfa Bio-tech which was acquired by Mundipharma in October 2018, pro-viding the firm with “global reach and expanded development and network capability for biosimilars.”

In 2018, Mundipharma received a final pan-European marketing authorisation from the European Commission for its pegfilgrastim.

Early this year, Mundipharma’s Pelmeg was one on the list of five biosimilar versions of pegfilgrastim added by France to its list of similar biologics. All five were listed against Amgen’s Neu-lasta as the reference brand for a newly-created similarity group by the country’s local medicines agency ANSM.

In March 2019, following the launch of Mundipharma’s Pelmeg in Germany, Ireland and the Netherlands, the company’s UK af-filiate Napp helped roll out the product in the UK as well.


BIOSIMILARS

European Nurses Offered Switching Guide In Eight LanguagesAIDAN FRY [email protected]

S pecialist nurses throughout Europe can now access a switch management guide for similar biological medicines in their own language. The European Specialist Nurses Or-

ganisation on 20 June unveiled translations into Dutch, French, German and Italian, as well as Polish, Portuguese and Spanish of the guidance that it launched in English a year ago.

Supported by off-patent industry association Medicines for Europe and brand body EFPIA, the guide on switching between similar biological medicines “is adapted to the specialized nurs-ing community, given their role in interacting with patients

being treated with biological, including bio-similar, medicines.”

Throughout the 48-page guide, ESNO illustrates its points with case studies, questions-and-answers and flowcharts. These include the example of a York regional hospitals trust in the UK saving £450,000 (US$571,500) in its first year of switching to biosimilar infliximab as well as a case study of how gainsharing can allow such hospital groups to fund extra nurses.


BIOSIMILARS

“Nurses have an essential function to ensure patient trust in their medical treatment, in making the link with the prescriber and contributing to patient adherence,” ESNO insisted, stressing the importance of “managing the process and communicating with the patient before, during and after the switch.”

“These medicines play a crucial role in the management of conditions such as cancer, auto-immune diseases and diabetes. Biosimilar medicines can increase patient access to life-saving treatments, enhance competition and contribute to healthcare system sustainability.”

Ber Oomen, ESNO’s executive director, commented: “Nurses play a very important role in guiding a patient through their treatment path. Our aim with the guide was to empower the nurse in their interactions with their patients. By translating the guide into seven additional languages, we aim to educate even more of the nursing community by providing the information in their language.”


“Nurses have an essential function to ensure patient trust in their medical treatment, in making the link with the prescriber and contributing to patient adherence”

BIOSIMILARS

Celltrion Reports Positive Rheumatoid Arthritis Data From Subcutaneous InfliximabAKRITI SETH [email protected]

C elltrion Healthcare’s new subcutaneous (SC) formulation of its CT-P13 biosimilar infliximab has shown positive results for the treatment of rheumatoid arthritis (RA) compared to

the intravenous version, according to the firm’s latest data. At this year’s European Congress of Rheumatology, EULAR, the

South Korean firm presented a two-part study investigating the pharmacokinetics, efficacy and overall safety of subcutaneous in-fliximab during the treatment period of one year, as well as non-inferiority of efficacy and safety profiles over a 30-week period.

The first part of the study involved 48 RA patients split into four equal cohorts at week six, three of which were treated with the subcutaneous version. “Data at 54 weeks showed that the subcutaneous formulation of CT-P13 was comparable in terms of the efficacy and safety when investigated against the intrave-nous formulation in rheumatoid arthritis,” Celltrion noted.

Meanwhile the second saw 348 patients randomized at week six into two groups for the two different formulations. The firm reported non-inferiority of the subcutaneous version at week 30, as well as comparable safety profiles at week six and similar dis-ease improvement responses up to week 22.

Talking about the potential of Celltrion’s subcutaneous infliximab to be an innovative biosimilar treatment for RA patients, Rieke Al-ten, rheumatology specialist at Schlosspark-Klinik Germany, said it “could address unmet needs in maintenance therapy and provide an affordable, convenient, and personalised treatment option.”

Korea’s Celltrion said that the SC formulation of CT-P13 “may enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a conve-nient method of administration”.

However, the company – which has already filed the subcuta-neous version with the European Medicines Agency as an exten-sion marketing authorization application – refused to comment further on any launch plans or filing pathways.

According to Celltrion, long-term treatment with CT-P13 was safe and efficacious – based on drug survival, disease activity measure-ments and adverse events – which it observed in a separate five-year analysis of medical records by collecting data from 491 patients.

INNOVATION IN DRUG ADMINISTRATIONTalking about providing physicians with accessible treatment

options for patients, whether intravenous or subcutaneous, Hy-oung-Ki Kim, vice chairman at Celltrion said, “such innovations in drug administration are shown to really benefit patients.”

Kim pointed out that “being able to offer CT-P13 SC with the new pharmaco-economic value expected with a dual formula-tion of infliximab could offer patients a more convenient treat-ment option, reducing the time spent in hospitals.”

Early this year, Celltrion presented data at the 14th congress of the European Crohn’s and Colitis Organisation (ECCO) dem-onstrating that the SC formulation of CT-P13 was comparable in terms of efficacy and safety with the IV formulation for the treat-ment of Crohn’s disease up until week 54, indicating that CT-P13 SC could be a future alternative infliximab treatment. Celltrion said, “auto-injection was shown to be a viable administration method for CT-P13 SC.”





FDA Adds Transparency On Paragraph IVs In Bid To Spur CompetitionAIDAN FRY [email protected]

Decisions on 180-day generic mar-ket exclusivity, the number of po-tential first applicants qualifying for

such exclusivity, the date of approval for the first applicant or applicants, the date of first commercial marketing, and the expiration date of last qualifying patent will hence-forth all be added to the database of para-graph IV patent certifications published by the US Food and Drug Administration.

Acting FDA commissioner Ned Sharpless said the improvements to “one of the agen-cy’s most viewed databases for industry” would “improve transparency and predict-ability for generic drug applicants to help in-crease timely access to high-quality, lower-cost generic drugs.” The updated data points from 18 June, he explained, “may allow generic applicants to make more informed business decisions about which of their spe-cific generic drug applications have a higher likelihood of being approved sooner.”

“This data,” Sharpless added, “may also provide more public transparency into instances in which the FDA approves an abbreviated new drug application with exclusivity, but the generic product is not marketed for an extended time, which among other reasons may signal ‘gaming’ tactics in the generics market.”

Since March 2004, the FDA’s paragraph IV list has included the name of the drug prod-uct, dosage form, strength or strengths and the reference listed drug’s new drug appli-cation number, as well as the date on which the first substantially complete application containing a paragraph IV certification of patent invalidity, unenforceability or non-infringement was submitted to the agency.

SERVES ULTIMATE GOAL OF MORE GENERIC APPROVALS

Under the agency’s Drug Competition Ac-tion Plan unveiled in 2017, the FDA commit-ted to enhancing efficiency of the develop-ment and approval of abbreviated new drug applications, “with the ultimate goal of more approvals, thereby helping to increase access to high-quality, lower-cost generic drugs.”

“The FDA believes that additional in-

formation regarding 180-day exclusivity for specific drug products may support this DCAP goal by providing greater clar-ity to ANDA applicants regarding the ear-liest date when they may be able to ob-tain final approval,” the agency explained.

From its 18 June update of the para-graph IV list, the FDA intends to add several information fields to the existing data. These are:

• Number of Potential First Applicant ANDAs SubmittedThis column indicates the number of substantially complete ANDAs that contained a paragraph IV certification to at least one patent listed for the RLD in the FDA’s Orange Book patent register on the first date such a certi-fication was submitted. The agency says it may adjust this number over time for a given drug, for example if it grants a request for reconsideration of its refusal to receive a relevant ANDA.

• 180-Day Decision StatusThis column indicates if the FDA has made, or has deferred, a decision re-garding eligibility for 180-day exclu-sivity for a product. Specifically, this column indicates whether: (1) the agency has approved at least one first applicant’s ANDA and considered that first applicant’s drug product eligible for 180-day exclusivity at the time of approval; (2) the FDA approved a first applicant, but did not make a determi-nation regarding eligibility for exclusiv-ity at the time of approval; (3) the FDA tentatively approved a subsequent ap-plicant solely on the basis of a first ap-plicant’s eligibility for 180-day exclusiv-ity at a time that none of the grounds for forfeiture were found to apply; or (4) the FDA determined that 180-day exclusivity has been extinguished – for example, if all first applicants have for-feited or voluntary relinquished eligi-bility for 180-day exclusivity.It is possible, the agency notes, that it may have made adecision on non-forfeiture of 180-day exclusivity, such

as on the basis of provisions around failure to obtain tentative approval within 30 months of ANDA filing, but then subsequently find that an appli-cant has forfeited exclusivity based on new events, such a failure to mar-ket the approved generic. Noting that the need to analyze the multitude of factors that can affect eligibility for exclusivity, and to “make a decision in the context of specific ANDAs that are otherwise eligible for approval”, the FDA says the column will be cumulative, with the most recent decision reflected first. “If the FDA has not made any of the above determina-tions, this column will be blank,” it adds.

• 180-Day Decision Posting DateThis column reflects the month and year in which FDA updated the para-

“One area we have

identified to help spur

investment in generic

drug development

is the availability of

resources that may

help applicants predict

when their application

may be able to receive

final approval and

when they may

begin marketing

their product”

– Ned Sharpless



graph IV certification list to reflect the corresponding 180-day decision status. This data will be cumulative, with the most recent decision date reflected first.

• Date of First Approval of ‘ First Applicant’ ANDAThis column indicates the first date on which a first applicant’s ANDA received final approval. If there are multiple first applicants, only the date of the first approval is posted.

• Date of First Commercial Marketing This column reflects the date of first commercial marketing by any first ap-plicant. This data, in conjunction with the Date of First Approval of ‘First Ap-plicant’ ANDA column, provides the timeframe between the dates a first applicant’s ANDA was approved and the date when a first applicant began commercial marketing. If an ANDA is determined to be eligi-ble for 180-day exclusivity, the agen-cy posts a patent challenge or ‘PC’ code in its “Exclusivity Data” section of the Orange Book to only the approved ANDA(s) eligible for 180-day exclusiv-ity upon any first applicant’s commer-cial marketing. This indicates the date on which the 180-day exclusivity will expire. If the agency defers making a decision on whether an approved ANDA(s) is eligible for 180-day exclu-sivity, no PC code will be entered. The agency intends to post approval let-ters for first applicant ANDA(s) in its Drugs@FDA database.

• Expiration Date of Last Qualifying PatentThis column lists the last expiration date of any patent(s) that qualifies any first applicant for 180-day exclusiv-ity for a given drug. It indicates when 180-day exclusivity will no longer be available due to expiry of the relevant patent, but does not reflect any pedi-atric exclusivity for the RLD associated with the last qualifying patent.If there are multiple applications sub-mitted on the first day, the patents that have at least one paragraph IV certification amongst all the submis-sions will be posted. For example: Applicant 1 includes paragraph IV cer-tifications to patents A, B, C, but para-graph III certifications deferring final

approval until after patents D, E and F have expired. Applicant 2 filed para-graph IV certifications to patents A, B, D and E, and paragraph IIIs to patents C and F. The single expiration date that is last-in-time for patents A, B, C, D and E would be posted on the paragraph IV certification list. The expiration date for patent F would not be considered, because both applicants have submit-ted a PIII certification to this patent.

At present, the additional data pro-vided over the original paragraph IV cer-tification list is sparse. However, two new entries provide a degree of extra clarity.

A listing for halobetasol propionate 0.01% lotion equivalent to the Bryhali plaque psoriasis treatment that Bausch Health’s Ortho Dermatologics launched last year reveals not only a first applicant ANDA date of 20 March 2019, but also that there is one ANDA submitted to date and that the last blocking patent, US patent 8,809,307, expires on 2 November 2031.

NEW LISTINGS CITE SINGLE ANDA APPLICANTS

Similarly, the certification list reveals that one ANDA has to date been submitted, on 29 April this year, for generics of Arbor’s Horizant (gabapentin enacarbil) 300mg and 600mg extended-release tablets. The last qualifying patent, US patent 8,795,725, expires on 10 June 2029.

The FDA is making no promises when it will fill in the extensive blanks on the certification list, beyond stating that the new columns “will be updated retrospec-tively as practicable.”

Sharpless acknowledged that potential ANDA applicants may previously have been able to infer from the first filing date whether an earlier filer might be eligible for 180-day exclusivity. But he insisted the greater transparency for both industry and the public would spur competition post-exclusivity, and where exclusivity had been relinquished or forfeited. “Our data shows that there are significant price decreases once there are at least three ge-neric drugs on the market,” he remarked.

Commenting on the FDA sharing the number of applicants that are poten-tially eligible for 180-day exclusivity, the acting commissioner believed “this information may inform other generic manufacturers’ decisions on whether to

develop a generic drug for that product.”While the FDA had granted tentative or

final approval to more than 2,000 ANDA applications over the past two years, Sharpless admitted that “there is more we may be able to do to facilitate a stable, competitive market.”

“We are working hard to reduce approval times and to enhance the efficiency of cer-tain aspects of the submission process for generic drug applicants,” he highlighted. “We also are striving to provide the industry with greater transparency in order to pro-vide greater certainty around timing of mar-ket entry and empower more informed de-cisions on how to prioritize their resources.”

“One area we have identified to help spur investment in generic drug development is the availability of resources that may help applicants predict when their application may be able to receive final approval and when they may begin marketing their product - providing patients timelier access to high-quality, lower-cost medicines.”

Such initiatives would, he pointed out, come on top of the agency’s previous efforts to help bolster the competitive-ness of the generics market that have in-cluded: taking steps to support complex generics development and application review; prioritizing the review of certain generics; and publishing a list of off-pat-ent, off-exclusivity brand drugs.

GUIDANCE COMING ON COURT ORDERS TO CEASE MARKETING

“Related, though uncommon, sometimes a generic drug manufacturer previously grant-ed final approval for a specific product may be court-ordered to cease marketing due to patent infringement,” Sharpless observed. “To help ensure there is a transparent pro-cess for how we handle post-approval pat-ent-infringement court orders and convert a final approval to a tentative approval, we intend to provide clarity to industry on how we handle this process in the near future.”

Additional guidelines and “other im-portant policy steps” would follow to assist generics applicants with greater clarity and transparency under DCAP, he promised, as the FDA looked to foster the competition that would reduce prices, and thereby improve access to medicines in the interests of public health.




BIOSIMILARS

Magellan Rx Pushes For Switching To Oncology BiosimilarsPENELOPE MACRAE

M agellan Rx Management, the pharmacy benefit-manage-ment arm of US managed-care

specialist Magellan Health, is mounting a campaign to get customers and medi-cal providers to adopt oncology biosimi-lars which it says could help lower stag-gering drug costs.

The Scottsdale, Arizona-based compa-ny says it is undertaking the drive ahead of the market entry of oncology biosimi-lars in the US expected this year. The PBM – which offers health-care management services to health plans, managed-care organizations, labor unions, government agencies and other customers – says its goal is to maintain and expand access to effective treatments while delivering “sig-nificant drug-spend savings.”

Magellan Rx is readying “our health-plan customers for the upcoming en-trance of biosimilars to the oncology cat-egory and helping them take advantage of cost-savings while ensuring clinical efficacy and safety,” according to the di-vision’s senior vice-president of specialty clinical solutions, Kristen Reimers.

A ‘MULTI-PRONGED APPROACH’“Our oncology biosimilar initiative takes a multi-pronged approach, including es-

tablishment of plan-specific goals, robust provider education and outreach and partnership with our customers with the goal to maximize potential savings, mini-mize disruption and improve outcomes for patients,” Reimers said.

Under its oncology biosimilar program, the company said it will assess and devel-op clinical protocols while educating and communicating with oncologists. Another thrust will be at the pharmacy level, lever-aging the company’s oncology know-how to incorporate biosimilars into manage-ment-use programs such as medical prior authorization and provider reimbursement.

According to the 2018 Magellan Rx Medical Pharmacy Trend Report, oncology agents make up 34% of the total medical pharmacy spend by commercial plans. Three oncology brands with expected bio-similar availability in 2019 make up $9bn in US drug sales and almost $50m in annual drug spend per 1m covered commercial lives. With use of biosimilars, Magellan Rx projects savings could be in the range of at least $5m-$8m per 1m covered lives.

BUILDS ON SUCCESS WITH INFLIXIMABThe PBM says its push to increase use of oncology biosimilars aims to build on the success of its program targeting

Magellan Rx and its health-plan customers

“are in a prime position to embrace

biosimilar availability of these high-cost drugs and produce

real savings for all involved”

gaining wider acceptance of biosimilar formulations of a high-cost autoimmune therapy, infliximab, used to treat gas-troenterological and rheumatology ail-ments. That scheme, it said, has resulted in drug-cost savings of more than 30% in the first year of operation.

Pfizer’s Inflectra infliximab-dybb bio-similar has allowed health plans which take a “comprehensive management ap-proach” – switching all patients receiving infliximab for management of gastroen-terological or rheumatological diseases to infliximab – to achieve up to 86% biosimilar use, resulting in 34% drug-cost savings, Magellan Rx said. Health plans that have used a “softer approach,” under which only new patients are asked to use the biosimilar instead of the Remicade reference brand, have seen their biosimi-lar use climb to as high as 75%.

In its program to shift drug utilization to lower-cost biosimilar versions of inflix-imab, a team of pharmacists developed a clinical policy working with physician of-fices and hospitals to ensure appropriate utilization for each patient’s situation.

“These are difficult-to-manage thera-pies,” Steve Cutts, Magellan Rx senior vice president and general manager, specialty, noted separately. But using drug-management expertise, Magellan Rx and its health-plan customers “are in a prime position to embrace biosimilar availability of these high-cost drugs and produce real savings for all involved,” not only through management-use pro-grams “but also by negotiating enhanced discounts for biosimilar versions.”

Magellan Rx Management said in its 2019 Medical Pharmacy Trend Report that 64% of payers indicated pricing of biosimilars would have the biggest im-pact on their reimbursement decisions, with the expectation that three of the top-spend oncology agents could have biosimilars on the market in 2019.

Currently marketed biosimilars are, on average, sold at a 47% list-price discount from their branded reference products and an 18% lower net price-discount in Medi-care Part B, which covers outpatient doctor and hospital drug spending, according to the US Association for Accessible Medi-cines and its Biosimilars Council.


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The ANDA Holder Program fee schedule for Fiscal Year 2019 was published by FDA in August 2018, and the fees increased by 17% from the previous year. Fees were as follows:

This is a significant expense for many firms. Those with a modest number of ANDAs will again be paying substantial fees for products they may not even currently market or are identified as Discontinued in the Orange Book. For a small- or medium-tier company this can be a dramatic hurdle simply to retain the assets they worked so hard to own.

Discontinued ANDAs are still considered approved ANDAs for user fee purposes unless the approval is withdrawn. And once withdrawn, ANDAs become virtually impossible to reactivate. Your asset may be gone forever. Further, no one yet knows what will happen to the ANDAs identified as “not marketed” from last year’s one-time marketing status report as submitted to the FDA.

A PROVEN SolutionNow in its third year, ANDA Repository, LLC. offers significant user-fee relief and a solution for companies with discontinued ANDAs or drug products not currently marketed. Like with a parking lot, car owners need space for their cars, whether in use or not. At ANDA Repository, in exchange for the space to park (and a fee), car owners transfers title of the cars to the parking lot owner. The former car owners can, with appropriate notice, resume ownership when they choose to use the car again. Since the parking lot owner has enough cars, this venture benefits for all the parties involved, and the cars remain safe and secure.

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FY2019 GDUFA ANDA Holder Fees Increased by 17% …. What Increase Will FY2020 Bring????

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