applied strategic 10 years vision for biosimilars
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applied strategic
10 years experience in biosimilars: launch to the future. What matters most?
Presentation by Dr Richard Littlewood
9 March 2016
8th Biosimilars Congregation
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Note
• This is a copy for distribution of a presentation made by Dr. Richard Littlewood reflecting on 10 years of experience in biosimilars, predicting what matters most for the future.
applied strategic 2
Analytics
What we all know? Definition of similarity concept for biologic medicines defined a new market for biosimilars
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Preclinical
PK/PD
Clinical Trials
Process development
Source: McCamish 2011, CMHP/437/04
Biological Characterization
Physiochemical Characterization
“A company may choose to develop a new biological medicinal product claimed to be “similar” to a
reference medicinal product”
CHMP/437/04
What do we expect? Rapid growth to $35B global market for biosimilars, predicted by observers
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Biosimilars global sales [2013-2020, $B]
60%
CAGR
Biosimilars
2013 2020
Biologics
175
285
Source: Merck Serono 2014, Blackstone & Joseph 2013, EGA 2015, Evaluate Group 2014
When did it start? Radical regulatory affairs innovation by EMEA, 2004 and key guidance launched biosimilars
applied strategic Source: applied strategic analysis EMA
Legal progress
Regulatory progress
2001 2002 2003 2004 2005 2006
Directive 2003/63/EC “Annex I” biosimilars
recognition
Directive 2004/27/EC published
Directive 2004/27/EC
in law
First biosimilar approved
Product guidelines
hGh, insulin, EPO, G-CSF
Comparability guidelines
Quality, non-clinical, clinical
guidelines
Where did it start? In Europe work started pre-2000; alternative biologics versions were marketed in LATAM also
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Europe1998: Start development of
Binocrit® (epoetin alfa)
Mexico1999: launch of Bioyetin
(epoetin alfa)
Source: applied strategic analysis
What is the impact? Early product launches in Europe highlight commercial and patient access success
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• Launch of biosimilar Epoetin alfa in Europe
• 5 year healthcare cumulative savings to Germany, €0.6B
• Typically 35% cost reduction
• 255,000 patient-years exposure
Biosimilar Epoetin Alfa Launch 2007
Commercial & patient access success
Source: applied strategic analysis
What is the impact? A relatively small set of biosimilar products are currently marketed
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Omnitrope
Silapo
EpoHexal
Binocrit
Abseamed
Tevagrastim
Ratiograstim
Biograstim
Retracrit
Nivestim
Remsima
Ovaleap
Inflectra
Grastofil
Bemfola
Accofil
Abasaglar
Benepali
Zarzio
FilgrastimHexal
20162006 2011
Source: GaBI, Biosimilars approved in Europe 2016
European product approvals
What is the impact? Few companies own a majority of the assets: market looks an oligopoly…
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Omnitrope
Silapo
EpoHexal
Binocrit
Abseamed
Tevagrastim
Ratiograstim
Biograstim
Retracrit
Nivestim
Remsima
Ovaleap
Inflectra
Grastofil
Bemfola
Accofil
Abasaglar
Benepali
Zarzio
FilgrastimHexal
20162006 2011
Source: GaBI, Biosimilars approved in Europe 2016
European product approvals
Assets owned by companies with portfolio of biosimiars
What is the future? Patent expiry, freedom to operate for many biologics defines a $B expansion of opportunity
Monoclonal antibodies approved/ under review in EU/ US [Patent expiry]
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<2020 >2020
Oncology
Non-on-cology
17
32
Source: applied strategic analysis
• 49 monoclonal antibody products have potential for biosimilar launch
• Launch of biosimilar versions of these products represents a step change in opportunity size
Potential value $20-30B
Expiry of patent, year
What is the future? New biosimilar products – based on antibodies – imply increasing manufacturing complexity
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Trade Name (INN) Originator Approval dateTysabri® (Natalizumab) Biogen Idec 2004Lucentis® (Ranibizumab) Roche/ Novartis 2006Cimzia® (Certolizumab) UCB 2009Stelara® (Ustekinumab) Johnson & Johnson 2009Eylea® (Aflibercept) Bayer/ Regeneron 2011Zaltrap® (Aflibercept) Sanofi/ Regeneron 2012Prolia®/Xgeva® (Denosumab) Amgen 2011Benlysta® (Belimumab) GlaxoSmithKline 2011Soliris® (Eculizumab) Alexion 2007, 2011
Source: applied strategic analysis
• Future products with potential to be biosimilars are based on antibodies• Greater manufacturing complexity, defining a special capability need
What is the future? Success with biosimilars is driving increasing simplicity in evidence needed for approval
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“a confirmatory clinical trial may not be necessary”
EMA 2014
“waiving clinical trials may be accomplishable for biosimilar
rhG-CSF”
EMA 2015
“pre-licensing safety study, immunogenicity assessment
waived?
EMA 2015
“PK PD results may make a comparative efficacy study
unnecessary”
FDA 2015
Source: applied strategic analysis
What is the future? A broad range of competitors now are present: partners are a major part of the business
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Merck Serono, MerckPfizer, Daiichi-SankyoBoehringer Ingelheim,
Biogen IdecBaxter, Lilly, Amgen
Sandoz, TevaHospira, Mylan
STADA, Dr. Reddy’s, actavis. Cipla, Gedeon
Richter
FujifilmSamsung
GE HealthcareCelltrion
Innovative companies
Genericsmanufacturers Others
BioconLonza
FormyconPatheon
IntasIBA Bioton
ZydusBroughton
ZydusWockhardt
CMCRentschler
Key partners: supporting development, contract development, manufacturers
Competitors: Commercializing biosimilar products
Source: applied strategic analysis
What drives success? First commercial phase. Success factors: protein characterization, regulatory affairs
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Development Clinical Regulatory Launch Commercial
Cell line to product development; protein
characterization; comparability
Agency relationships, strategic leadership;
pathway interpretation
Tender management, pricing strategy.
Customer awareness
Customer awareness, defending against
restrictions;Policy management
Success Factors for Biosimilar Competition: First Commercial Phase (2006-2016)
What drives success? Next 10 years Success factors: commercial power, speed to market
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Development Clinical Regulatory Launch Commercial
Complex protein manufacture
R&D partnerships
Capability to deliver clinical studies rapidly
Marketing & Sales power
Race to market
Success Factors for Biosimilar Competition: Second Commercial Phase (2017-2027)
Speaker profileDr. Richard Littlewood
• Richard is the founder of the strategy firm applied strategic
• is a physician with clinical practice experience and a management consultant who has worked for 15 years addressing strategic and operational issues in health, pharma
• He is a UK GMC registered physician, has an MA from Trinity College, Cambridge and is a graduate of the Sloan Masters management program at London Business School.
• Richard pioneered on biosimilars strategy and has extensive experience in many developed and emerging markets.
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[applied strategic founder]
Dr. Richard Littlewood
• Adviser to global pharmaceutical companies involved in biosimilar development in Europe, USA and emerging markets since 2006
[Conflicts]
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