IP & Communication
Biopharmaceuticals such as therapeutic therapeutic proteins, DNA vaccines, monoclonal antibodies, fusion proteins, gene therapy, stem cell therapy, antisense nucleotides, RNA viruses •
Manufacturing process based on living cells or organisms which have inherently variable metabolisms •
Aspirin - 21 atoms/180 atoms/180 Da
Large, highly variable & complex molecules in comparison to the chemical drug (small molecules) •
Fragile nature, biological activity depends upon structural integrity •
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Effective treatment for many diseases
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Expensive
Intact antibody antibody - >20,000 atoms/150, 000 Da
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10% and 15% of the world pharmaceutical market Biopharmaceutical sales - ~ $108bn $108bn market market in 2010 from from ~ 200 product, 160bn by 2016 - Annual growth growth rate of 7.8% 7.8% - Top 10 products contribute for 50% of the market ma rket Prime targeted areas - oncology, oncology, inflammation, hormones & growth factors Indian Indian prospe prospects cts - Majo Majorr focu focus: s: immu immuno nobi biol ologi ogics cs & vacc vaccin ines es - Targe argett rev revenue enue US$5 US$5.8 .8 bn by 20 2012 12 - Represents a CAGR CAGR of 26% & estimated to be 89.1% by 2014
Source: 1. Evaluate Pharma, Newport Premium, IMS MIDAS, Lonza 2. FICCI, “Overview “Overvi ew of the Biotech sector in India” (2005)
Three types
Biosimilar Interchangeable Biobetters Biosimilar
Simi Simila larr versi ersion onss of inn innovator tor biol biolog ogic ic drugs rugs appr approoved thr throu ough gh legislative legislative pathway pathway •
Exact copy of the original product impossible due to inherent complexities •
Follow-on manufacturer has no access to the innovator’s clone, cell bank, fermentation and purification processes •
Expected Biosimilar: similar in terms ter ms of safety, safety, purity and potency of the product with no clinically clinically meaningful differences •
Host cell: Primary factor governing the nature of protein product
Interchangeable
Subs Substi titu tuta tabl blee for for inno innova vato torr drug drug with withou outt the the inte interve rvent ntio ionn of heal health th care care pro provide viderr •
Expected to produce same clinical result as the innovator drug •
Clinical studies must demonstrate that switching of the innovator drug does not result in diminished efficacy or safety in patients •
Biobetters •
Biob Biobet ette ters rs or bios biosup uperi eriors ors:: impr improoveme vement ntss to inno innova vato torr drug drug
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Second Second genera generatio tionn biologi biologicc
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Enhanc Enhanced ed bioav bioavail ailabi abilit lityy or reduce reducedd immuno immunogen genici icity ty
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Deve Develo lopm pmen enta tall time timeli line ne ~ 8 years years
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Data Data requ equirem iremen ents ts & Data Data ex excclusi lusivi vity ty ~ 12 years ears
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Clinic Clinical al safety safety requir requireme ements nts
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Earlie Earlierr failur failure: e: - Pharm Pharmac acok okin inet etic icss (Pk) (Pk) - Pharma Pharmaco cody dyna nami micc (Pd) (Pd) - Immuno Immunogen genici icity ty shift shift Regula Regulatory tory and Marketi Marketing ng app appro roval valss – dyna dynami micc and and evol evolvi ving ng
Timelines pushed: Patent Term Extensions (PTE), Patent Term Adjust Adjustmen ments ts (PTA), (PTA), Supple Supplemen mentary tary Protec Protectio tionn Certific Certificate ate (SPC) (SPC) •
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High High price price comp compet etit itio ionn du duee to comm commer erci cial al & manu manufa fact ctur urin ingg hu hurd rdle less
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Increased Increased affordabilit affordabilityy – majo majorr ince incent ntiv ivee to swit switch ch ~ 48 biol biologi ogica cals ls (inc (inclu ludi ding ng block lockbu bust ster ers) s) to go offoff-pa pate tent nt in the the next next two two deca de cade dess pro providi viding ng impe impetu tuss to mark market et de deve velo lopm pmen entt
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Branded pharmaceuticals accelerating accelerating into biosimilar biosimilar market
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More pipeline products in later stages of development
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Increased market share & collaboration through licensing, mergers & acquisitions a cquisitions agreement Increased IP valuation & due diligence for commercialization Diverse uptake market – less regulated approvals
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Sandoz: first company to push for biosimilar approval Launched Launched biosimil biosimilar ar growth growth hormone, hormone, filgrastim filgrastim & epoetin Teva, Hospira, Ratiopharm: well established biosimilar companies Hospira Hospira has an agreement agreement with with Celltrion Celltrion to develo developp biosimilar biosimilar monoclonal monoclonal antibodies antibodies Innovator companies such as Roche, Amgen focusing on biosimilars to protect original brand Other companies to join the bandwagon: bandwagon: Stada, Cipla, Boehringer Ingelheim, GE Healthcare, Healthcare, Samsung with Biogen Idec, Baxter with Momenta Leading Indian Players: Dr. Dr. Reddy’s Reddy’s Laboratories, Intas Biopharmaceuticals, Biocon, Wockhardt,
Reliance Life Sciences
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In Europe, Canada & Japan: Biosimilars Biosimilars approved approved through through a regulatory pathway The EMEA of European Union is leading in regulation of bisomilar approval In US: Biosimilar pathway recently implemented in Feb, 2012 by FDA Guidelines provided provided as Biologics Price Competition and Innovation Act (BPCIA)
In India: Biosimilar approval is semi-regulated
For additional information on various biologics/biosimilars for oncological, inflammatory disorders & the one serving as immunomodulators immunomodulators write to:
[email protected] [email protected]
