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applied strategic biosimilars success

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applied strategic founder, Dr Richard Littlewood defined success factors for the next 10-year commercial phase of biosimilars at the 8th Biosimilars Congregation, held in London.

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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 applied strategic 1
Analytics What we all know? Definition of similarity concept for biologic medicines defined a new market for biosimilars applied strategic 2 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 applied strategic 3 Biosimilars global sales [2013-2020, $B] 60% CAGR Biosimilars Biologics 175 285 2013 2020 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” biosimiars 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 applied strategic 5 Europe 1998: Start development of Binocrit® (epoetin alfa) Mexico 1999: launch of Bioyetin (epoetin alfa) Source: applied strategic analysis
What is the impact? Early product launches in Europe highlight commercial and patient access success applied strategic 6 • 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 applied strategic 7 Omnitrope Silapo EpoHexal Binocrit Abseamed Tevalgrastim Ratiograstim Biograstim Retracrit Nivestim Remsima Ovaleap Inflectra Grastofil Bemfola Accofil Abasglar 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… applied strategic 8 Omnitrope Silapo EpoHexal Binocrit Abseamed Tevagrastim Ratiograstim Biograstim Retracrit Nivestim Remsima Ovaleap Inflectra Grastofil Bemfola Accofil Abasglar 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] applied strategic 9 Oncology Non- oncology 17 32 <2020 >2020 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 applied strategic 10 Trade Name (INN) Originator Approval date Tysabri® (Natalizumab) Biogen Idec 2004 Lucentis® (Ranibizumab) Roche/ Novartis 2006 Cimzia® (Certolizumab) UCB 2009 Stelara® (Ustekinumab) Johnson & Johnson 2009 Eylea® (Aflibercept) Bayer/ Regeneron 2011 Zaltrap® (Aflibercept) Sanofi/ Regeneron 2012 Prolia®/Xgeva® (Denosumab) Amgen 2011 Benlysta® (Belimumab) GlaxoSmithKline 2011 Soliris® (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 applied strategic 11 “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 applied strategic 12 Merck Sorono, Merck Pfizer, Daiichi-Sankyo Boehringer Ingelheim, biogen idec Baxter, Lilly, Amgen Sandoz, Teva Hospira, Mylan STADA, Dr. Reddy’s, actavis. Cipla, Gideon Richter Fujifilm Samsung GE Healthcare Celltrion Innovative companies Generics manufacturers Others Biocon Lonza Formycon Patheon Intas IBA Bioton Zydus Broughton Zydus Wockhardt CMC Rentschler 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 applied strategic 13 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 applied strategic 14 Development Clinical Regulatory Launch Commercial Complex protein manufacture R&D partnerships Capability to delivery clinical studies rapidly Marketing & Sales power Race to market Success Factors for Biosimilar Competition: Second Commercial Phase (2017-2027)
Speaker profile Dr. 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. 15 [appliedstrategic 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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applied strategic biosimilars success

  • 1. 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 applied strategic 1
  • 2. Analytics What we all know? Definition of similarity concept for biologic medicines defined a new market for biosimilars applied strategic 2 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
  • 3. What do we expect? Rapid growth to $35B global market for biosimilars, predicted by observers applied strategic 3 Biosimilars global sales [2013-2020, $B] 60% CAGR Biosimilars Biologics 175 285 2013 2020 Source: Merck Serono 2014, Blackstone & Joseph 2013, EGA 2015, Evaluate Group 2014
  • 4. 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” biosimiars 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
  • 5. Where did it start? In Europe work started pre-2000; alternative biologics versions were marketed in LATAM also applied strategic 5 Europe 1998: Start development of Binocrit® (epoetin alfa) Mexico 1999: launch of Bioyetin (epoetin alfa) Source: applied strategic analysis
  • 6. What is the impact? Early product launches in Europe highlight commercial and patient access success applied strategic 6 • 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
  • 7. What is the impact? A relatively small set of biosimilar products are currently marketed applied strategic 7 Omnitrope Silapo EpoHexal Binocrit Abseamed Tevalgrastim Ratiograstim Biograstim Retracrit Nivestim Remsima Ovaleap Inflectra Grastofil Bemfola Accofil Abasglar Benepali Zarzio FilgrastimHexal 20162006 2011 Source: GaBI, Biosimilars approved in Europe 2016 European product approvals
  • 8. What is the impact? Few companies own a majority of the assets: market looks an oligopoly… applied strategic 8 Omnitrope Silapo EpoHexal Binocrit Abseamed Tevagrastim Ratiograstim Biograstim Retracrit Nivestim Remsima Ovaleap Inflectra Grastofil Bemfola Accofil Abasglar Benepali Zarzio FilgrastimHexal 20162006 2011 Source: GaBI, Biosimilars approved in Europe 2016 European product approvals Assets owned by companies with portfolio of biosimiars
  • 9. 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] applied strategic 9 Oncology Non- oncology 17 32 <2020 >2020 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
  • 10. What is the future? New biosimilar products – based on antibodies – imply increasing manufacturing complexity applied strategic 10 Trade Name (INN) Originator Approval date Tysabri® (Natalizumab) Biogen Idec 2004 Lucentis® (Ranibizumab) Roche/ Novartis 2006 Cimzia® (Certolizumab) UCB 2009 Stelara® (Ustekinumab) Johnson & Johnson 2009 Eylea® (Aflibercept) Bayer/ Regeneron 2011 Zaltrap® (Aflibercept) Sanofi/ Regeneron 2012 Prolia®/Xgeva® (Denosumab) Amgen 2011 Benlysta® (Belimumab) GlaxoSmithKline 2011 Soliris® (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
  • 11. What is the future? Success with biosimilars is driving increasing simplicity in evidence needed for approval applied strategic 11 “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
  • 12. What is the future? A broad range of competitors now are present: partners are a major part of the business applied strategic 12 Merck Sorono, Merck Pfizer, Daiichi-Sankyo Boehringer Ingelheim, biogen idec Baxter, Lilly, Amgen Sandoz, Teva Hospira, Mylan STADA, Dr. Reddy’s, actavis. Cipla, Gideon Richter Fujifilm Samsung GE Healthcare Celltrion Innovative companies Generics manufacturers Others Biocon Lonza Formycon Patheon Intas IBA Bioton Zydus Broughton Zydus Wockhardt CMC Rentschler Key partners: supporting development, contract development, manufacturers Competitors: Commercializing biosimilar products Source: applied strategic analysis
  • 13. What drives success? First commercial phase. Success factors: protein characterization, regulatory affairs applied strategic 13 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)
  • 14. What drives success? Next 10 years Success factors: commercial power, speed to market applied strategic 14 Development Clinical Regulatory Launch Commercial Complex protein manufacture R&D partnerships Capability to delivery clinical studies rapidly Marketing & Sales power Race to market Success Factors for Biosimilar Competition: Second Commercial Phase (2017-2027)
  • 15. Speaker profile Dr. 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. 15 [appliedstrategic founder] Dr. Richard Littlewood • Adviser to global pharmaceutical companies involved in biosimilar development in Europe, USA and emerging markets since 2006 [Conflicts]