1. BIOSIMILARSEMERGING MARKET IN INDIA1Presentation by :U.PRUTHVIRAJRoll.no.43DOPMNIPER, MOHALI.

2. INTRODUCTION The Indian Pharmaceutical Industry has been a global leader inthe cause of providing high quality affordable medicines to theworld The first generation of biological drugs, which have introducedmany revolutionary treatments to life-threatening and rareillnesses, is currently facing patent expiration The similar biologics industry, globally has been growingstupendously ,but still in its infancy2

3. Therapeutic products typically derivedfrom living systems and can also beproduced by using biotechnologicalprocedures.Biologic A biological product produced bybiotechnological methods and claimedto be similar in terms ofsafety, efficacy and quality to areference biologic, which has beengranted a marketing authorization inIndiaSimilar biologic3Officially approved subsequent version of innovators biologicsafter expiry of patent

4. Biosimilars.Europe- EMEA Fallow- on BiologicsUS- FDA Subsequent Entry Biologics (SEBs).CANADA- BGTD4

5. Similar biologicsINDIA5

6. Global sales of biologics US $ 157 billions,2012 Global sales of biosimilars US $ 693 million,20126 Indian biologics market crossed US $ 3 billion,2011-12Source : Global use of medicines outlook through 2016, IMS HEALTH-JULY2012MARKET OVERVIEWSource : Ministry of external affairs,GOIIndian biosimilar market

7. BIOLOGICSCORE THERAPY AREA OF BIOLOGICS MARKET( $ US BILLION)Insulin 15.9Anti-TNF 15.8Oncology 12.5EPO 7.6Multiple sclerosis 7.3CSF-G 5.0Blood coagulation 3.1Ocular antineovascular 2.0Anti viral (no-HIV) 1.5Others 16.57Source : IMS HEALTH 2011

8. TOP BIOLOGICS8BRANDSource : FIERCE PHARMA

9. Regulatory guidelines set by :INDIADBTCDSCOU.SFDAEUROPEANUNIONEMEA9

10. EUROPE :THE FIRST MARKET Today, the continent is the largest biosimilars market in theworld with robust guidelines EMEA( European Medicines Authority) Reviews marketing authorization applications for biologics. Award either positive or negative opinion based on evaluationof quality, safety and efficacy measures After the product receives a positive opinion EC(EUROPEANCOMMISION) will grant marketing authorization valid for theEuropean union. Sandoz/Novartis, Stada, Hospira, Medice and Teva.101st biosimilar - Omnitrope in 2006 for Somatropin(HGH)

11. US MARKET Largest Biologics market The Patient Protection and Affordable Care Act , March 23rd2010 Public Health Service Act The U.S. FDA issued three draft guidance documents onFeb 9th ,201211

12. INDIA12AUGUST 15th ,2012

13. COMPETENT AUTHORITIES INVOLVED INAPPROVAL PROCESS RCGM(Review Committee on Genetic Manipulation) Functions in Department of Biotechnology( DBT), Ministry ofScience & Technology, Government of India(GOI) Responsible for authorizing import & export for R&D andreview of data up to preclinical evaluation GEAC(Genetic Engineering appraisal Committee) Functions under ministry of Environment & Forests Responsible for review & approval of activities involvinglarge-scale use of genetic engineered organisms & productsthere of in R&D , industrial production , environmental releaseand filed applications13

14. CDSCO ( Central Drugs Standard Control Organization) Headed by DCGI under Ministry of Health & Family Welfare Responsible for clinical trail approval ,permission formarketing, manufacturing and grant of import& exportlicense State FDA works with CDSCO in each state & is responsiblefor issuance of license to manufacture similar biologics inIndia14Source : Guidelines on Similar Biologics:Regulatory Requirements forMarketing Authorization in India, GOI, 2012GOI prepared this guidelines by referring EMEA guidelines, ICHguidelines, WHO guidelines

15. Head-to-head characterization studies are required to comparethe similar biologics and the reference biologic15GMPstandardsQualitytestpre-clinicaltesting toGLPclinicaltestingto GCPPostmarketingsafetyAPPROVAL PROCESS

16. Continued..16Reference biologic should be licensed inIndiaIn case, Reference biologic is not marketedin India, 4years market exclusivity given forinnovator product .This period of 4 years may be reduced incase of National Healthcare Emergency

17. FORCES SHAPING THE BIOSIMILARS MARKETBiologics patent expiries Rising Health CostsBurgeoning agingpopulation and diseaseslike cancer, diabetes & R.IPrice of biologicsBIOSIMILARSMARKET17cost-effective alternatives to biologics reflects the growing demand for thesespeciality drugs

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19. HURDLESTECHNOLOGIAL BARRIERSINTERCHANGEABILITYUNCERTAIITIESHIGHERGESTATIONPERIODHIGH COSTTO DEVELOP19Average cost estimates range fromUS$80-120 millionReluctance from physiciansto prescribe and usebiosimilarsSophisticated technologies &processesCost of Biosimilars products to consumers in emerging markets is stillrelatively high unlike small molecule generics that are at heavy discountsto originators.

20. OPPORTUNITIESOligopolistic marketLess entry of CompetitorsGovernment initiatives to encourageBiosimilars.20

21. Companies should clear oftheir strategic relevance within the organizationPortfolio fit Financial suitabilityTherapy areas-size ofpotentialSynergies with the valuechainTHOSE LOOKING FOR JOINING BIOSIMILARS JOURNEY..

22. ClinicaldevelopmentMarket accessManufacturingcostsSales andmarketing22VALUE CHAIN

23. INDIAN SCENARIOWhile almost all major Indian drug makers have outlined plans, identifiedproducts and set aside investment budgets to develop a robust productpipeline, some have even started rolling them into the market.23About 20 Indiancompanies enteredinto marketPresently , therewere about 15epoetin, 8 G-CSFand 4 insulinbiosimilars available

24. INDIAN COMPANIES24The current biosimilars portfolio of Dr Reddys Laboratories constitutes offilgrastim, peg-filgrastim, Rituximab and Darbepeotin alpha, which havecommercial presence in 13 emerging countries.Soon, I expect to see Dr Reddys biosimilars entering developed markets,Chairman K Anji Reddy says.Lupin is now on its way and plans to soon launch its first of two biosimilar drugsfor oncology in India by the end of this year. The company currently has a totalof 10 proteins in different stages of developmentReditux, a copy of Rituximabmanufactured by Dr.Reddys,has beenavailable in India since 20071stbiosimilarin INDIA

25. Cipla are making huge investments in India and outside toacquire manufacturing facilities and potential productpipelines in the biosimilar segment25 Wockhardt is among the early entrants and has developedinsulin and analoguesRecently opened a large biotech park inAURANGABAD, designed according to U.S & EMEAStandardsRanbaxy, Biocon, Shantha Biotech, Reliance Life Sciences, Panacea Biotecand Intas Biopharmaceuticals are also on the way

26. 26Ranbaxy holds 40% stakein Zenotech for marketingbiosimilarsDeveloping antibodiesMarch 2012, Biocon and Pfizer hadamicably concluded their alliance tocommercialize Biocons biosimilarversions of Insulin and Insulin analogproductsCo-develop and market the low-costversion of a biotech cancer medicinefilgrastim (G-CSF) in North America andEurope

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28. CONCLUSION The biosimilars market is in the nascent stage of the industry lifecycle with limited market and product development experience.However, there is a significant market opportunity from patentexpiries High initial investments are still a major barrier for new entrants. Collaborations among large pharmaceutical companies withfinancial capabilities and specialty biotech companies with technicalexpertise are expected The strong integration of marketing and research and developmentskills is the key to success in the biosimilars market.28Companies need commitment, along with a well-charted strategicplan, investment and technical synergy because biosimilars is a long-termgame, with many hurdles on the way.

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