Regulatory Affairs—Pharmaceutical

FDA Releases Program for Approvalof Biosimilars

—Clinical Trials Usually Will Be Needed

ROCKVILLE, MD 2/9/12—The U.S. Food andDrug Administration today issued draft guidance doc-uments on biosimilar product development, ScientificConsiderations in Demonstrating Biosimilarity to aReference Product and Quality Considerations inDemonstrating Biosimilarity to a Reference ProteinProduct, which are reprinted in the documents sectionof this issue.

It is clear that approval of most candidate productswill require clinical trials, a point that had been insome question. Physicians generally supported requir-ing them, whereas manufacturers hoped they wouldrarely be necessary.

The Patient Protection and Affordable Care Actamended the Public Health Service Act to create anabbreviated approval pathway under x351(k) for bio-logical products that are demonstrated to be highlysimilar (biosimilar) to or interchangeable with anFDA-licensed product. ‘‘Under x351(k) of the PHSAct, a proposed biological product that is demonstrat-ed to be biosimilar to a reference product can rely oncertain existing scientific knowledge about the safety,purity, and potency of the reference product to supportlicensure.’’ The hope is that biosimilars will be muchcheaper, as generic small-molecule drugs are cheaperthan brand name products, but it is not clear therewill be a great price differential, given the difficult ap-proval pathway and the complexities of manufacturingand quality control of the proteins.

SCIENTIFIC CONSIDERATIONSIN DEMONSTRATING BIOSIMILARITY

The scientific considerations document discussesthe standards the FDA will use when considering bio-similarity, specifically

� A stepwise approach, which can include a com-parison of the proposed and the reference productwith respect to structure, function, animal toxici-ty, human pharmacokinetics (PK) and pharmaco-dynamics, immunogenicity, and clinical safetyand effectiveness;

� The totality-of-the-evidence approach FDAwill use;

� General scientific principles for conducting the re-quired studies (including clinical trial design issues).

Additional topics covered by this guidance are:

� The complexities of therapeutic protein products,including those related to manufacturing;

� Use of data from studies comparing a proposedproduct with a product licensed outside of butnot in the U.S.;

� Postapproval safety monitoring.

Applications must contain data demonstrating bio-similarity that have been derived from

� Analytical studies demonstrating a high degree ofsimilarity notwithstanding minor differences inclinically inactive components;

� Animal studies (including assessment of toxicity);and

� ‘‘A clinical study or studies (including the assess-ment of immunogenicity and pharmacokinetics orpharmacodynamics) that are sufficient to demon-strate safety, purity, and potency in one or moreappropriate conditions of use for which the refer-ence product is licensed and intended to be usedand for which licensure is sought for the biologi-cal product.’’

Of particular note:

In general, the clinical program for a 351(k)application must include a clinical study or stud-ies (including an assessment of immunogenicityand [pharmacokinetics] or [pharmacodynam-ics]) sufficient to demonstrate safety, purity,and potency in one or more appropriate condi-tions of use for which the reference product is li-censed and intended to be used and for whichlicensure is sought for the biological product,as set forth in the PHS Act. The scope and mag-nitude of clinical studies will depend on the ex-tent of residual uncertainty about the biosimilarityof the two products after conducting structuraland functional characterization and possible ani-mal studies. The frequency and severity of safetyrisks and other safety and effectiveness concernsfor the reference product may also affect the de-sign of the clinical program. Lessening the num-ber or narrowing the scope of any of these typesof clinical studies (i.e., human PK, PD, clinicalimmunogenicity, or clinical safety and effective-ness) should be scientifically justified by thesponsor. [Footnotes omitted.]

Postmarketing safety monitoring will be required,and consultation with FDA throughout product devel-opment is strongly recommended.

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QUALITY CONSIDERATIONSIN DEMONSTRATING BIOSIMILARITY

The quality document traces the history of proteinproduct manufacturing, including the regulatorychanges made over time in light of new information.

All product applications should contain acomplete and thorough chemistry, manufactur-ing and controls (CMC) section that providesthe necessary and appropriate information (e.g.,characterization, adventitious agent safety, pro-cess controls, and specifications) for the productto be adequately reviewed. This guidance de-scribes considerations for additional CMC infor-mation that may be relevant to the assessment ofbiosimilarity between two protein products. Thisguidance should be used as a companion to otherguidances available from FDA that describe theCMC information appropriate for evaluation ofprotein products. We encourage early interactionwith FDA to discuss specific CMC issues thatmay arise for an applicant’s proposed biosimilarproduct.

In addition to comparative analytical stud-ies, an assessment of whether a proposed productis biosimilar to a reference product generallywill include animal studies (including the assess-ment of toxicity) and a clinical study or studies(including the assessment of immunogenicityand pharmacokinetics and/or pharmacodynam-ics). .

A scientifically sound characterization thatprovides a comprehensive understanding of thechemical, physical, and biological characteris-tics of the proposed biosimilar product is essen-tial to the design of the manufacturing processand to the conduct of development studies.(Footnotes omitted.)

When determining whether products are highlysimilar, it is necessary to consider the expression sys-tem, the manufacturing process, the physicochemicalproperties of the protein, its functional activities, re-ceptor binding and immunochemical properties, possi-ble impurities, the reference product and standards, thefinished product, and its stability. A list of relevantguidances previously issued by FDA is appended.

INTELLECTUAL PROPERTYCONSIDERATIONS

Approval of biosimilars has raised the stakes for in-tellectual property protection, causing biotechnologyand pharmaceutical companies to assess their patentpositions and look at other protection approaches, aBoston patent attorney said.

According to Konstantin Linnik of Nutter McClen-nen & Fish, formerly senior corporate counsel at Pfizer,companies are likely to make small changes in theirproteins to create what he called ‘‘biobetter’’ products.A question then arises whether the biobetter will be el-igible for its own patent. Trade secret protection mightprove more effective in protecting against competition.Linnik noted that such protection can be highly effec-tive, citing the formula for Coca-Cola as a great success.

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Call for Regulatory Oversightof Genetic Testing

—Experts Reject ‘‘Paternalism’’ Objections

CHAPEL HILL, N.C. 12/7/11—In today’s issue ofJAMA, James Evans and Jonathan Berg of the Univer-sity of North Carolina call for new oversight of whole-genome and whole-exome genetic testing.

‘‘Th[e recent] upheaval in sequencing technologypresents new challenges to implementation and regula-tion, forcing physicians to consider what genomics hasto offer patients, clinicians, and consumers, ultimatelyprompting a consideration of the role of paternalism inmedicine,’’ they write. They note that although havinginformation about diseases for which they are at riskcould help consumers, the effects could be devastatingif a person learns that he or she will develop a severeand untreatable disease such as Huntington’s chorea.The authors believe that genetic testing should be sub-jected to the same regulatory program as standard labo-ratory tests, an idea sure to draw fire from the companiesnow selling direct-to-consumer tests. Evans and Bergalso object to the persons who run the test being theones to deliver the findings to the patient. Rather, geneticcounselors should discuss the findings.

They criticize the argument that this practice is pa-ternalistic and therefore should be banned.

‘‘Medicine is, to at least some extent, an inherently pa-ternalistic endeavor simply because of an inevitableasymmetry in knowledge and because those who practicemedicine are pledged to avoid causing harm,’’ they state.

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Legitimacy of FDA GuidancesCalled into Question

—Court of Appeals Says FDA Cannot Stop

Bulk Compounding

ATLANTA, GA. 12/16/11—A decision handeddown by the 11th Circuit Court of Appeals today hascast a cloud over the legal status of the U.S. Foodand Drug Administration’s guidance documents.

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The decision, in United States v. Franck’s Lab, Inc.,No. 5:10-cv-147-Oc-32TBS (M.D. Fla.; filed Sept. 9,2011), said that the FDA does not have the authorityto stop pharmacists from filling prescriptions withproducts compounded from bulk drugs. Specifically,the court noted that ‘‘traditional pharmacy compound-ing in the context of a pharmacist–veterinarian–patientrelationship is contrary to [the] congressional intent’’of the Federal Food, Drug, and Cosmetic Act(FDCA) and that allowing FDA to enjoin a pharmacist’straditional, widespread, and state-authorized practice ofbulk compounding of animal drugs ‘‘could destabilizethe pharmacy profession and leave many animal pa-tients without necessary medication.’’

The case came to court after 21 polo ponies werekilled by a mathematical error in compounding adrug. The Florida State Pharmacy Board investigatedthe incident and resolved the matter, but the FDAinspected the compounding pharmacy, Franck’s Lab,and cited it for what it called ‘‘illegal drug manufactur-ing.’’ The agency said such compounding was a ‘‘perse’’ violation of the FDCA.

GUIDANCES: EXPANSIONOF REGULATORY POWERS?

After examining various guidances issued by FDAon the question of compounding, the court focusedon a 2003 document (FDA Compliance Policy GuideSec. 460.400, Pharmacy Compounding of Drugs forUse in Animals), issued without soliciting public com-ments and to considerable public disagreement. In thecourt’s view, the FDA was out of line: Congress had‘‘focus[ed] governmental resources upon the commer-cial distributors of drugs rather than upon the trainedpharmacists and physicians who must reconstitutedrugs for a patient to use on a smaller scale.’’ The ques-tion was not whether FDA was authorized to regulatecompounding used as a ‘‘disguise for manufacturing,’’which FDA clearly is, but rather whether it was attempt-ing to extend its control by action against an individualpharmacy. The court also noted that FDA had promisedfor some time to issue an improved guidance on veter-inary drug compounding but had not done so. In thecourt’s view, FDA could not use a guidance documentto upset industry expectations it had helped to create‘‘without explanation.’’

According to Karla L. Palmer and Jeffrey N. Gibbs,Directors with Hyman, Phelps & McNamara PC, theFranck case calls into question the legal import ofFDA guidance documents, which some view as at-tempts by the agency to expand its regulatory powers.Of particular concern is that the guidances do not gothrough the notice-and-comment rule-making processordinarily required of federal regulations but rather aresimply published. Given the way in which these docu-

ments are being used, they should be considered ‘‘sub-stantive’’ and ‘‘rulemaking’’ and thus require noticeand comment, as documented in previous cases,1

according to these authors The issue raised is impor-tant, as the number of such guidance is rising rapidly(The year 2009 saw the release of 169 such docu-ments.) Moreover, negative comments on guidancedocuments often are ignored, according to the Wash-ington Legal Foundation, which published the com-mentary on the Franck case.

OTHER INSTANCES OF REGULATORYACTIONS BASED ON GUIDANCES

The WLF reviewed recent FDA actions in cases inwhich Research Use Only (RUO) products are foundto be in use for clinical purposes. A proposed FDAdraft guidance would mandate that the manufacturerof the test immediately quit selling to the laboratorythat was using its test clinically. FDA also has saidthat even this draft guidance defines existing policyand cited it in a warning letter.

Another example discussed by WLF was the June2011 ‘‘Guidance for Industry and FDA Staff: Classifi-cation of Products as Drugs and Devices and Addi-tional Product Classification Issues’’ that subjectscertain products long considered devices to the regula-tions governing drugs. As WLF noted, this is unques-tionably a substantive change, especially as FDAbegan applying the new rules even before public re-lease of the draft guidance.

FDA has appealed the Franck decision.Palmer and Gibbs closed their commentary by not-

ing that ‘‘Guidance documents take less work to pro-mulgate, go through less review, and can be revisedmore readily [than ordinary regulations]. However,ease of use does not excuse FDA from the need tocomply with the Administrative Procedures Act.’’

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Consumer and Environmental Groups DemandLabeling of All Materials Containing

Nanotechnology Ingredients

—FDA Maintains It Is Material Properties, Not

Method of Manufacture, That Should Govern

ROCKVILLE, MD 1/3/12—A group of consumeradvocates has sued the U.S. Food and Drug

1See Community Nutrition Institute v. Young, 818 F.2d 943, 946(D.C. Cir.1987); American Hospital, 834 F.2d 1037 (D.C. Cir1987); Syncor Int’l Corp. v. Shalala, 127 F.3d 90, 95 (D.C.Cir. 1997).

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Administration for not responding to a petition it filedin 2006 demanding that all products containing nano-materials be so labeled and that such products be sub-ject to additional health and environmentalassessments before approval.

Nanomaterials have aroused considerable anxietybecause they may (but do not necessarily) have prop-erties different from those of larger-scale productsmade with the same ingredients. Some opponentshave demanded an end to all research and develop-ment of such products, but many are already on themarket.

The lawsuit is led by the International Center forTechnology Assessment joined by Friends of theEarth, Food and Water Watch, the Center for Environ-mental Health, the ETC Group, and the Institute forAgricultural and Trade Policy.

In June 2011, FDA issued a draft guidance for in-dustry on the subject but has no specific regulationsin place. The agency maintains that the risks of nano-materials are specific to the material and not the tech-nology.

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Brain Infection Linked to AnotherMonoclonal Antibody

—Lymphoma Product Is Latest in Series

ROCKVILLE, MD 1/13/12—The U.S. Food andDrug administration has received reports of fivecases of progressive multifocal leukoencephalopathyin patients taking Seattle Genetics Inc. and TakedaPharmaceutical Co.’s recently approved antineoplasticdrug Adcetris (brentuximab). As a result, the agencystrengthened the drug’s warning label.

Adcetris is approved for patients with recurrentHodgkin’s lymphoma or anaplastic large-cell lym-phoma.

The brain infection, caused by a virus presentnaturally in the brains of many people that can bereactivated if the immune system is disturbed, hasbeen documented in a number of patients receivingdrugs that suppress the immune system in some way,including several biotechnology products. Patientshelped by the products have blocked drives by con-sumer advocates to have the agents removed fromthe market.

As is usual in these cases, the patients having PMLafter taking Adcetris have received a number of treat-ments, so it is not clear that Adcetris was the cause ofthe derepression of the causative virus.

The monoclonal antibody binds to the CD30 recep-tor on lymphoma cells and delivers a chemotherapeu-tic agent in a targeted fashion.

The FDA also warned that the risk of lung damageis higher in patients receiving both Adcetris and bleo-

mycin, which is well known to cause lung injury.Thus, the drugs should not be used together, theagency said.

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China Says It Will Restrict UnapprovedStem Cell Treatments

—Procedures Have Produced No Benefit

and Considerable Harm; Whether

New Law Will Have an Effect in Doubt

BEIJING, CHINA 1/10/12—China has announcedthat it will close all the centers in the country that pro-vide unapproved stem cell treatments.

Many people have travelled to China to obtain stemcell treatments that are not approved by regulatoryagencies in the U.S. and Europe in the hope of allevi-ation or cure of serious conditions such as spinal cordinjury and Alzheimer’s disease. However, the recordof the treatments is abysmal, with no cures beingreported, few patients benefitting to even a minor de-gree, and several patients suffering severe adverse re-actions, including induction of cancer, that have led toseveral deaths. The patients have paid thousands oreven tens of thousands of dollars for the untested treat-ments, which are advertised on the Internet.

The Chinese Ministry of Health said it will stopaccepting new applications for approval of stem cellprograms and will tighten its regulation of programsalready in place. Moreover, unless a treatment is med-ically approved, hospitals will be barred from chargingpatients for it.

The order was issued jointly by the Ministry and theState Food and Drug Administration.

Although scientists and physicians said they werepleased with the government action, there is consider-able doubt that the order will be enforced, as many ofthe programs are run by Chinese government entitiessuch as the People’s Liberation Army and policeforces. An earlier law that required hospitals offer-ing advanced medical technology to obtain approvalfor its use had little effect on medical practice in thecountry.

In a comment on this and other attempted reformsof ‘‘stem cell tourism,’’ Zubin Master, Ph.D., a re-search associate at the University of Alberta’s HealthLaw and Science Policy Group, and David B. Resnik,J.D., Ph.D., a bioethicist and Institutional ReviewBoard Chair at the National Institute for Environmen-tal Health Sciences, National Institutes of Health,wrote in the September 14, 2011, issue of The Scientistthat the hype surrounding the supposed enormous ben-efits of stem cells is being exploited for monetary gainwithout helping patients. In some cases, the harm doneto patients has been sufficient to cause medical

Biotechnology Law Report � Volume 31, Number 2 145

licenses to be revoked. Nevertheless, ‘‘the number offraudulent clinics [is] vast and growing,’’ no doubtaided in part by the politically motivated criticism offormer U.S. President George W. Bush’s curtailmentof the creation and use of human embryonic stemcells.

‘‘But perhaps more can be done [to curtail unap-proved stem cell treatments],’’ Master and Resniksay. ‘‘Published recently in EMBO Reports, we put for-ward a new strategy to combat stem cell tourism—onethat actively involves scientists.’’ The authors call atten-tion to the translational guidelines recently published bythe International Society for Stem Cell Research, whichare supported by a patient handbook on stem cell ther-apies and a website offering information about real andfraudulent stem cell treatments.

‘‘Yet the question remains whether this educationalinformation reaches patients, and whether it detersthem from seeking snake oil abroad. How many scien-tific societies or patient advocacy groups must providesufficient educational materials for this to be a truly ef-fective effort?’’

Patients and their families need more education onhow scientific research works and how the regulatoryprocess operates so they quit demanding immediatemiracles is the sum of the Master and Resnik advice.International guidelines to stop clinics offering untest-ed ideas are another good idea. However, the authorsare not sanguine about the prospects that many coun-tries will enact the necessary laws, given the financialincentives for looking the other way and the near-impossibility of obtaining monetary compensation ifa treatment does harm, meaning that illegitimate treat-ment centers have little to fear.

Master and Resnik also suggest that stem cell scien-tists ‘‘use existing . (material transfer agreements) toshare materials and reagents only with responsible sci-entists. This would require researchers to evaluate therequestor’s CV, supplementary documentation, a clin-ical protocol, and website before providing reagentssuch as stem cell lines, nucleic acid sequences, growthfactor-enriched cocktails, or purified proteins to oth-ers. Those requesting materials would have to signan MTA, which would outline the intended purposesof the materials. For example, MTAs for sharingstem cells that are not clinical grade or are not beingused to develop clinical-grade cells should stipulatethat the cells are to be used for non-clinical researchpurposes only.

‘‘Although our proposal places limits on scientificopenness and sharing, we believe it is necessary tohave such restrictions in this situation in order to pre-vent greater harms—potentially worsening the condi-tion of patients who receive fake treatments and thepossibility of reducing public trust and undermininglegitimate stem cell research.’’

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India Needs a Biotechnology RegulatoryFramework

—Present Uncertainty Is Inhibiting Research

and Development

BANGALORE, INDIA 2/7/12—According to Dr.Kiran Mazumdar Shaw, the chair of Biocon, the lackof a proper regulatory framework is hurting biotech-nology in India. The industry would have great poten-tial if the government provided the proper legalenvironment, Shaw believes.

At the Bangalore India-Bio 2012 conference goingon here, Shaw noted that India has become an exporterof genetically engineered Bt cotton and has reduced itsimports of pesticides as a result of growing the plants.She has hopes that use of biotechnology could lowerthe need for fossil fuels and recommended creationof a market such as Nasdaq as a means of raisingmoney to support related R&D.

Union Minister for Health and Family WelfareGhulam Nabi Azad said that a task force to developregulatory guidelines has been established consistingof representatives from private industry, global corpo-rations, and domestic industries.

Dr. M. K. Bhan, Secretary of the Department of ITTand Science and Technology, noted that a single set ofregulations has been established for both pharmaceuti-cals and biotechnology and wished for passage of thelong-delayed National Biotechnology RegulatoryAuthority of India Bill by Parliament. He remarkedthat only about 20% of the money spent by the govern-ment is creating intellectual property. Strategy paperson biomanufacturing are expected from the Depart-ment by midyear.

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Texas Medical Board Establishes ApprovalMechanism for Stem Cell Trials

—Governor’s Treatment Involved His Own Cells,

Not Embryonic Cells

AUSTIN, TX 2/10/12—The Texas Medical Boardhas approved a tentative policy for the regulation ofthe clinical use of adult stem cells. Final approvalcould be granted April 13.

The policy would allow stem cell therapy only incases in which a review committee independent ofthe potential users grants permission. According toBoard President Dr. Irwin Zeitler, ‘‘this policy will af-ford the public protection that doesn’t exist now forproducts not approved by the Food and Drug Admin-istration. At the same time, it doesn’t hinder progress.’’

It is hoped that the policy will avoid a showdownwith the U.S. Food and Drug Administration, whichhas begun taking action against providers of stem

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cell therapies, many of which do not have agency ap-proval.

Texas Governor Rick Perry underwent stem celltherapy for a back problem last year. There was an im-mediate uproar over his use of therapy that he suppos-edly was denying to other Texans because of his firmopposition to embryonic stem cell research. To thechagrin of the critics, it soon became known that thecells used were not embryonic stem cells but rathercells harvested from Perry’s own body.

Perry has said the treatment was beneficial.

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European Medicines Agency IssuesPharmacogenetics Guidance

—Such Studies Will Be Required in Some

Circumstances

LONDON, U.K. 2/13/12—The European Medi-cines Agency today published guidelines for the useof pharmacogenetic methods for pharmacokineticevaluation of drugs and biologics. Such methods areemployed to assess the effects of genetic variabilityon the actions and disposition of drugs in patients.Important variations include single-nucleotide poly-morphisms and copy-number variations.

The guidelines were adopted by the Committee forMedicinal Products for Human Use in January andwill take effect August 1, 2012.

According to the guidelines, pharmacogenetic stud-ies should be required when the ‘‘magnitude of theinter-individual variation in drug exposure is so highas to likely influence the safety and/or efficacy of thedrug in genetically variable populations.’’ Indicationsthat variations of this magnitude are present usuallywould be derived from the findings of animal studiesor early human trials. Such studies also would be re-quired if clinical trials suggest differences in safety orefficacy that cannot be explained by other mechanisms.

Pharmacogenetic studies also are recommended,but not yet required, in other situations such as unex-plained differences among ethnic groups. Advice onthe design and conduct of pharmacogenetic studiesis included in the document, as are guidelines for inter-preting the results and incorporating the findings into aproduct’s labeling.

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Will Approval of New Treatments BeHastened by TREAT?

—Bill with That Goal Introduced; FDA Opposed,

But BIO Favors It

WASHINGTON, D.C. 2/15/12—The Biotechnol-ogy Industry Organization (BIO) today praised Sen.

Kay Hagan (D-N.C.) for introducing the Transformingthe Regulatory Environment to Accelerate Access toTreatments (TREAT) Act. In BIO’s view, the Act‘‘will help break the institutional barriers to a fasteridea-to-market pathway and speed new cures to pa-tients most desperately in need.. The legislationwill help the U.S. Food and Drug Administrationretain its leadership position as the global ‘gold stan-dard’ for regulatory science and consumer protec-tion.. It is simply unacceptable that in the UnitedStates, as patients suffer and die, the time to take anew drug from discovery to patient is 10 to 15 years.Moreover, regulatory uncertainty is having a majornegative impact on the private funding of biomedicalinnovation. .’’

The Act has not been met with favor at the U.S.Food and Drug Administration. CommissionerDr. Janet Woodcock called TREAT ‘‘a new schemefor getting drugs on the market that substantial-ly lowers the standards for safety or for effective-ness.’’

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Forbes Says Big Drug Companies Are InhibitingImprovement of Drug Approval Process

NEW YORK, N.Y. 2/12—An article in Forbescharges that large pharmaceutical companies havebeen undermining efforts to reauthorize the Prescrip-tion Drug User Fee Act.

According to former U.S. Food and Drug Admin-istration Commissioner Dr. Andrew von Eschen-bach, bureaucratic inertia at the FDA causedclinical trials conducted from 2003–2006 to take70% longer and be far more complex and costlythan those conducted from 1999–2002. As a result,biotechnology companies have largely shied awayfrom developing drugs for common conditions suchas heart disease in favor of genetic diseases andrare cancers, where marketing permission often canbe obtained by the accelerated approval process, inwhich tentative approval can be granted after PhaseII trials if a drug shows promise in a serious diseasefor which there is a good surrogate endpoint suchas tumor shrinkage.

The FDA can change its mind on such approvalslater, as it did recently in the case of Avastin foradvanced breast cancer. Marketing approval for thisindication was rescinded when women who receivedthe drug along with chemotherapy did not live lon-ger than those given chemotherapy alone, althoughmany patients said their lives had been improved byAvastin.

The article also notes that the accelerated approv-al process applies to life-threatening diseases and isnot available for serious chronic diseases such asdiabetes.

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‘‘While this problem has harmed patients by mak-ing it harder for them to gain access to new treatments,it’s been great for the big pharmaceutical companies,’’the article says. The Transforming the RegulatoryEnvironment to Accelerate Access to Treatments(TREAT) Act should help. But an earlier versionwas rejected after lobbying by PhRMA. That versionwould have offered accelerated approval to other clas-ses of drugs, such as the first one approved for a spe-cific and identifiable disease subpopulation or thoseaimed at patients unresponsive to, or intolerant of,existing treatments. In the view of Forbes, much ofthe opposition by the pharmaceutical companiesarose because if needed drugs could be approvedafter a Phase II study, biotechnology companieswould not need to seek out pharmaceutical partnersto cover their development costs.

The FDA also disapproves of TREAT (see previousstory).

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New Biotechnology Product Approval

Roche was told in December that the EuropeanCommission has approved its drug bevacizumab (Avas-tin) for the treatment of newly diagnosed advancedovarian cancer, a disease for which current therapy is in-adequate. The approval covers only the use of Roche’sproduct in combination with standard chemotherapy.

In clinical trials, addition of Avastin to chemother-apy led to significant prolongation of life.

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