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The U.S. FDA issued three draft guidance documents onFeb 9th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
18. 18
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..
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
27. 27
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.