SlideShare a Scribd company logo
1 of 32
BIOSIMILARS
EMERGING MARKET IN INDIA
1
Presentation by :
U.PRUTHVIRAJ
Roll.no.43
DOPM
NIPER, MOHALI.
INTRODUCTION
 The Indian Pharmaceutical Industry has been a global leader in
the cause of providing high quality affordable medicines to the
world
 The first generation of biological drugs, which have introduced
many revolutionary treatments to life-threatening and rare
illnesses, is currently facing patent expiration
 The similar biologics industry, globally has been growing
stupendously ,but still in its infancy
2
• Therapeutic products typically derived
from living systems and can also be
produced by using biotechnological
procedures.
Biologic
• A biological product produced by
biotechnological methods and claimed
to be “similar” in terms of
safety, efficacy and quality to a
reference biologic, which has been
granted a marketing authorization in
India
Similar biologic
3
Officially approved subsequent version of innovators biologics
after expiry of patent
• „Biosimilars‟.
Europe- EMEA
• ‘Fallow- on Biologics’
US- FDA
• „Subsequent Entry Biologics’ (SEBs).
CANADA- BGTD
4
• Similar biologics
INDIA
5
 Global sales of biologics US $ 157 billions,2012
 Global sales of biosimilars US $ 693 million,2012
6
 Indian biologics market crossed US $ 3 billion,2011-12
Source : Global use of medicines outlook through 2016, IMS HEALTH-JULY2012
MARKET OVERVIEW
Source : Ministry of external affairs,GOI
Indian biosimilar market
BIOLOGICS
CORE THERAPY AREA OF BIOLOGICS MARKET
( $ US BILLION)
Insulin 15.9
Anti-TNF 15.8
Oncology 12.5
EPO 7.6
Multiple sclerosis 7.3
CSF-G 5.0
Blood coagulation 3.1
Ocular antineovascular 2.0
Anti viral (no-HIV) 1.5
Others 16.5
7
Source : IMS HEALTH 2011
TOP BIOLOGICS
8
BRAND
Source : FIERCE PHARMA
Regulatory guidelines set by :
INDIA
DBT
CDSCO
U.S
FDA
EUROPEAN
UNION
EMEA
9
EUROPE :THE FIRST MARKET
 Today, the continent is the largest biosimilars market in the
world with robust guidelines
 EMEA( European Medicines Authority)
 Reviews marketing authorization applications for biologics.
 Award either positive or negative opinion based on evaluation
of quality, safety and efficacy measures
 After the product receives a positive opinion EC(EUROPEAN
COMMISION) will grant marketing authorization valid for the
European union.
 Sandoz/Novartis, Stada, Hospira, Medice and Teva.
10
1st biosimilar - Omnitrope in 2006 for Somatropin(HGH)
US MARKET
 Largest Biologics market
 The Patient Protection and Affordable Care Act , March 23rd
2010
 Public Health Service Act
 The U.S. FDA issued three draft guidance documents on
Feb 9th ,2012
11
INDIA
12
AUGUST 15th ,2012
COMPETENT AUTHORITIES INVOLVED IN
APPROVAL PROCESS
 RCGM(Review Committee on Genetic Manipulation)
 Functions in Department of Biotechnology( DBT), Ministry of
Science & Technology, Government of India(GOI)
 Responsible for authorizing import & export for R&D and
review of data up to preclinical evaluation
 GEAC(Genetic Engineering appraisal Committee)
 Functions under ministry of Environment & Forests
 Responsible for review & approval of activities involving
large-scale use of genetic engineered organisms & products
there of in R&D , industrial production , environmental release
and filed applications
13
 CDSCO ( Central Drugs Standard Control Organization)
 Headed by DCGI under Ministry of Health & Family Welfare
 Responsible for clinical trail approval ,permission for
marketing, manufacturing and grant of import& export
license
 State FDA works with CDSCO in each state & is responsible
for issuance of license to manufacture similar biologics in
India
14
Source : Guidelines on Similar Biologics:
Regulatory Requirements for
Marketing Authorization in India, GOI, 2012
GOI prepared this guidelines by referring EMEA guidelines, ICH
guidelines, WHO guidelines
Head-to-head characterization studies are required to compare
the similar biologics and the reference biologic
15
GMP
standard
s
Quality
test
pre-
clinical
testing to
GLP
clinical
testing
to GCP
Post
marketing
safety
APPROVAL PROCESS
Continued..
16
Reference biologic should be licensed in
India
In case, Reference biologic is not marketed
in India, 4years market exclusivity given for
innovator product .
This period of 4 years may be reduced in
case of National Healthcare Emergency
FORCES SHAPING THE BIOSIMILARS MARKET
Biologics patent expiries Rising Health Costs
Burgeoning aging
population and diseases
like cancer, diabetes & R.I
Price of biologics
BIOSIMILARS
MARKET
17
cost-effective alternatives to biologics reflects the growing demand for these
speciality drugs
18
HURDLES
TECHNOLOGI
AL BARRIERS
INTERCHANG
EABILITY
UNCERTAIITI
ES
HIGHER
GESTATION
PERIOD
HIGH COST
TO DEVELOP
19
Average cost estimates range from
US$80-120 million
Reluctance from physicians
to prescribe and use
biosimilars
Sophisticated technologies &
processes
Cost of Biosimilars products to consumers in emerging markets is still
relatively high unlike small molecule generics that are at heavy discounts
to originators.
OPPORTUNITIES
Oligopolistic market
Less entry of Competitors
Government initiatives to encourage
Biosimilars.
20
Companies should clear of
their strategic relevance within the organization
Portfolio fit Financial suitability
Therapy areas-size of
potential
Synergies with the value
chain
THOSE LOOKING FOR JOINING BIOSIMILARS JOURNEY..
Clinical
development
Market access
Manufacturing
costs
Sales and
marketing
22
VALUE CHAIN
INDIAN SCENARIO
While almost all major Indian drug makers have outlined plans, identified
products and set aside investment budgets to develop a robust product
pipeline, some have even started rolling them into the market.
23
About 20 Indian
companies entered
into market
Presently , there
were about 15
epoetin, 8 G-CSF
and 4 insulin
biosimilars available
INDIAN COMPANIES
24
The current biosimilars portfolio of Dr Reddy‟s Laboratories constitutes of
filgrastim, peg-filgrastim, Rituximab and Darbepeotin alpha, which have
commercial presence in 13 emerging countries.
“Soon, I expect to see Dr Reddy’s 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 drugs
for oncology in India by the end of this year. The company currently has a total
of 10 proteins in different stages of development
Reditux, a copy of Rituximab
manufactured by Dr.Reddy‟s,has been
available in India since 2007
1st
biosimilar
in INDIA
Cipla are making huge investments in India and outside to
acquire manufacturing facilities and potential product
pipelines in the biosimilar segment
25
 Wockhardt is among the early entrants and has developed
insulin and analogues
Recently opened a large biotech park in
AURANGABAD, designed according to U.S & EMEA
Standards
Ranbaxy, Biocon, Shantha Biotech, Reliance Life Sciences, Panacea Biotec
and Intas Biopharmaceuticals are also on the way
26
Ranbaxy holds 40% stake
in Zenotech for marketing
biosimilars
Developing antibodies
March 2012, Biocon and Pfizer had
amicably concluded their alliance to
commercialize Biocon‟s biosimilar
versions of Insulin and Insulin analog
products
Co-develop and market the low-cost
version of a biotech cancer medicine
filgrastim (G-CSF) in North America and
Europe
27
CONCLUSION
 The biosimilars market is in the nascent stage of the industry life
cycle with limited market and product development experience.
However, there is a significant market opportunity from patent
expiries
 High initial investments are still a major barrier for new entrants.
 Collaborations among large pharmaceutical companies with
financial capabilities and specialty biotech companies with technical
expertise are expected
 The strong integration of marketing and research and development
skills is the key to success in the biosimilars market.
28
Companies need commitment, along with a well-charted strategic
plan, investment and technical synergy because biosimilars is a long-term
game, with many hurdles on the way.
29
31
32

More Related Content

What's hot

MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
 
Ppt 1 overview of regulatory affairs and diff bodies_august2016_final
Ppt 1 overview of regulatory affairs and diff bodies_august2016_finalPpt 1 overview of regulatory affairs and diff bodies_august2016_final
Ppt 1 overview of regulatory affairs and diff bodies_august2016_finalRajashri Survase Ojha
 
10 Facts to pass the RAC (Regulatory Affairs Certification)
10 Facts to pass the RAC (Regulatory Affairs Certification)10 Facts to pass the RAC (Regulatory Affairs Certification)
10 Facts to pass the RAC (Regulatory Affairs Certification)pauljhon43
 
Regulation of biosimilar in India
Regulation of biosimilar in India Regulation of biosimilar in India
Regulation of biosimilar in India Palesh Rajkondawar
 
Comparison of Clinical Trial Application requirement of India, USA and Europe.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Comparison of Clinical Trial Application requirement of India, USA and Europe.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
 
Regulations for drug approval in USA, E.U & India
Regulations for drug approval in USA, E.U & IndiaRegulations for drug approval in USA, E.U & India
Regulations for drug approval in USA, E.U & IndiaDr. Pankaj Bablani
 
FDA Regulation of Combination Products
FDA Regulation of Combination ProductsFDA Regulation of Combination Products
FDA Regulation of Combination ProductsMichael Swit
 
NDA Application.pptx
NDA Application.pptxNDA Application.pptx
NDA Application.pptxVenugopal N
 
ANVISA regulatory authority of brazil
ANVISA regulatory authority of brazilANVISA regulatory authority of brazil
ANVISA regulatory authority of brazilGaurav Kr
 
Market authorisation checklist for brics countries
Market authorisation checklist for brics countriesMarket authorisation checklist for brics countries
Market authorisation checklist for brics countriesJAYA PRAKASH VELUCHURI
 
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRY
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRYEXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRY
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRYSai Datri Arige
 
Registration requirments for cis countries
Registration requirments for cis countriesRegistration requirments for cis countries
Registration requirments for cis countriesJAYA PRAKASH VELUCHURI
 
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPANMEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPANDeveshDRA
 
0rganisation of pharmaceutical industry
 0rganisation of pharmaceutical industry  0rganisation of pharmaceutical industry
0rganisation of pharmaceutical industry Ram Mohan S R
 
Organizaton chart of us fda.
Organizaton chart of us fda.Organizaton chart of us fda.
Organizaton chart of us fda.Rovil Goel
 
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, Definitions
Medical Devices Regulation (MDR)  2017/745 - Part I Purpose, Scope, DefinitionsMedical Devices Regulation (MDR)  2017/745 - Part I Purpose, Scope, Definitions
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, DefinitionsArete-Zoe, LLC
 

What's hot (20)

MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
 
Ppt 1 overview of regulatory affairs and diff bodies_august2016_final
Ppt 1 overview of regulatory affairs and diff bodies_august2016_finalPpt 1 overview of regulatory affairs and diff bodies_august2016_final
Ppt 1 overview of regulatory affairs and diff bodies_august2016_final
 
10 Facts to pass the RAC (Regulatory Affairs Certification)
10 Facts to pass the RAC (Regulatory Affairs Certification)10 Facts to pass the RAC (Regulatory Affairs Certification)
10 Facts to pass the RAC (Regulatory Affairs Certification)
 
Regulation of biosimilar in India
Regulation of biosimilar in India Regulation of biosimilar in India
Regulation of biosimilar in India
 
Comparison of Clinical Trial Application requirement of India, USA and Europe.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Comparison of Clinical Trial Application requirement of India, USA and Europe.
Comparison of Clinical Trial Application requirement of India, USA and Europe.
 
Regulations for drug approval in USA, E.U & India
Regulations for drug approval in USA, E.U & IndiaRegulations for drug approval in USA, E.U & India
Regulations for drug approval in USA, E.U & India
 
Cdsco ppt
Cdsco pptCdsco ppt
Cdsco ppt
 
FDA Regulation of Combination Products
FDA Regulation of Combination ProductsFDA Regulation of Combination Products
FDA Regulation of Combination Products
 
NDA Application.pptx
NDA Application.pptxNDA Application.pptx
NDA Application.pptx
 
ANVISA regulatory authority of brazil
ANVISA regulatory authority of brazilANVISA regulatory authority of brazil
ANVISA regulatory authority of brazil
 
Market authorisation checklist for brics countries
Market authorisation checklist for brics countriesMarket authorisation checklist for brics countries
Market authorisation checklist for brics countries
 
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRY
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRYEXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRY
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRY
 
Regulatory requirements for orphan drugs delivery
Regulatory requirements for orphan drugs deliveryRegulatory requirements for orphan drugs delivery
Regulatory requirements for orphan drugs delivery
 
ANDA
ANDAANDA
ANDA
 
Registration requirments for cis countries
Registration requirments for cis countriesRegistration requirments for cis countries
Registration requirments for cis countries
 
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPANMEDICAL DEVICE APPROVAL PROCESS IN JAPAN
MEDICAL DEVICE APPROVAL PROCESS IN JAPAN
 
0rganisation of pharmaceutical industry
 0rganisation of pharmaceutical industry  0rganisation of pharmaceutical industry
0rganisation of pharmaceutical industry
 
Organizaton chart of us fda.
Organizaton chart of us fda.Organizaton chart of us fda.
Organizaton chart of us fda.
 
Anvisa gudelines
Anvisa gudelinesAnvisa gudelines
Anvisa gudelines
 
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, Definitions
Medical Devices Regulation (MDR)  2017/745 - Part I Purpose, Scope, DefinitionsMedical Devices Regulation (MDR)  2017/745 - Part I Purpose, Scope, Definitions
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, Definitions
 

Viewers also liked

BIOSIMILARS: SCIENCE TO MARKET
BIOSIMILARS: SCIENCE TO MARKETBIOSIMILARS: SCIENCE TO MARKET
BIOSIMILARS: SCIENCE TO MARKETPriyesh Waghmare
 
Bio similar- An opportunities or challenge for Indian Company
Bio similar- An opportunities or challenge for Indian Company Bio similar- An opportunities or challenge for Indian Company
Bio similar- An opportunities or challenge for Indian Company Debashish Kar
 
Biosimilars Advantages and Disadvantages
Biosimilars Advantages and DisadvantagesBiosimilars Advantages and Disadvantages
Biosimilars Advantages and DisadvantagesVeeda CR
 
BIOSIMILARS - Regulation and Market Trends
BIOSIMILARS - Regulation and Market Trends    BIOSIMILARS - Regulation and Market Trends
BIOSIMILARS - Regulation and Market Trends Joseph Pategou
 
FDA Presentation on Biologics
FDA Presentation on BiologicsFDA Presentation on Biologics
FDA Presentation on BiologicsRobert Puopolo
 
SURVEY ON MODELLING METHODS APPLICABLE TO GENE REGULATORY NETWORK
SURVEY ON MODELLING METHODS APPLICABLE TO GENE REGULATORY NETWORKSURVEY ON MODELLING METHODS APPLICABLE TO GENE REGULATORY NETWORK
SURVEY ON MODELLING METHODS APPLICABLE TO GENE REGULATORY NETWORKijbbjournal
 
Reconstruction and analysis of cancerspecific Gene regulatory networks from G...
Reconstruction and analysis of cancerspecific Gene regulatory networks from G...Reconstruction and analysis of cancerspecific Gene regulatory networks from G...
Reconstruction and analysis of cancerspecific Gene regulatory networks from G...ijbbjournal
 
Emerging markets in india by Ashok Boddeda
Emerging markets in india by Ashok BoddedaEmerging markets in india by Ashok Boddeda
Emerging markets in india by Ashok BoddedaAshok Boddeda
 
Biosimilars market global revenue, trends, growth, share, size and forecast t...
Biosimilars market global revenue, trends, growth, share, size and forecast t...Biosimilars market global revenue, trends, growth, share, size and forecast t...
Biosimilars market global revenue, trends, growth, share, size and forecast t...Scalar Market Research
 
A Report on Pipeline of Biosimilars in India 2015
A Report on Pipeline of Biosimilars in India 2015 A Report on Pipeline of Biosimilars in India 2015
A Report on Pipeline of Biosimilars in India 2015 fydmanagementconsultants
 
Clinical development of biopharmaceuticals in India
Clinical development of biopharmaceuticals in IndiaClinical development of biopharmaceuticals in India
Clinical development of biopharmaceuticals in IndiaBhaswat Chakraborty
 
Case studies in Strategy: Teva
Case studies in Strategy: TevaCase studies in Strategy: Teva
Case studies in Strategy: TevaDan Saguy
 
Reducing technical and regulatory uncertinty in biosimilar development
Reducing technical and regulatory uncertinty in biosimilar developmentReducing technical and regulatory uncertinty in biosimilar development
Reducing technical and regulatory uncertinty in biosimilar developmentAjaz Hussain
 

Viewers also liked (20)

Biosimilars
BiosimilarsBiosimilars
Biosimilars
 
Biosimilars
BiosimilarsBiosimilars
Biosimilars
 
BIOSIMILARS: SCIENCE TO MARKET
BIOSIMILARS: SCIENCE TO MARKETBIOSIMILARS: SCIENCE TO MARKET
BIOSIMILARS: SCIENCE TO MARKET
 
Bio similar- An opportunities or challenge for Indian Company
Bio similar- An opportunities or challenge for Indian Company Bio similar- An opportunities or challenge for Indian Company
Bio similar- An opportunities or challenge for Indian Company
 
Biosimilars Advantages and Disadvantages
Biosimilars Advantages and DisadvantagesBiosimilars Advantages and Disadvantages
Biosimilars Advantages and Disadvantages
 
BIOSIMILARS - Regulation and Market Trends
BIOSIMILARS - Regulation and Market Trends    BIOSIMILARS - Regulation and Market Trends
BIOSIMILARS - Regulation and Market Trends
 
FDA Presentation on Biologics
FDA Presentation on BiologicsFDA Presentation on Biologics
FDA Presentation on Biologics
 
SURVEY ON MODELLING METHODS APPLICABLE TO GENE REGULATORY NETWORK
SURVEY ON MODELLING METHODS APPLICABLE TO GENE REGULATORY NETWORKSURVEY ON MODELLING METHODS APPLICABLE TO GENE REGULATORY NETWORK
SURVEY ON MODELLING METHODS APPLICABLE TO GENE REGULATORY NETWORK
 
Reconstruction and analysis of cancerspecific Gene regulatory networks from G...
Reconstruction and analysis of cancerspecific Gene regulatory networks from G...Reconstruction and analysis of cancerspecific Gene regulatory networks from G...
Reconstruction and analysis of cancerspecific Gene regulatory networks from G...
 
Emerging markets in india by Ashok Boddeda
Emerging markets in india by Ashok BoddedaEmerging markets in india by Ashok Boddeda
Emerging markets in india by Ashok Boddeda
 
Biosimilars market global revenue, trends, growth, share, size and forecast t...
Biosimilars market global revenue, trends, growth, share, size and forecast t...Biosimilars market global revenue, trends, growth, share, size and forecast t...
Biosimilars market global revenue, trends, growth, share, size and forecast t...
 
Biosimilars
BiosimilarsBiosimilars
Biosimilars
 
A Report on Pipeline of Biosimilars in India 2015
A Report on Pipeline of Biosimilars in India 2015 A Report on Pipeline of Biosimilars in India 2015
A Report on Pipeline of Biosimilars in India 2015
 
Clinical development of biopharmaceuticals in India
Clinical development of biopharmaceuticals in IndiaClinical development of biopharmaceuticals in India
Clinical development of biopharmaceuticals in India
 
Biosimilars, biogenerics and fo bs
Biosimilars, biogenerics and fo bsBiosimilars, biogenerics and fo bs
Biosimilars, biogenerics and fo bs
 
Regulatory Perspectives on Biosimilars in Europe
Regulatory Perspectives on Biosimilars in EuropeRegulatory Perspectives on Biosimilars in Europe
Regulatory Perspectives on Biosimilars in Europe
 
Ifpma - Points to consider - biotherapeutics vs small molecule medicines - Wo...
Ifpma - Points to consider - biotherapeutics vs small molecule medicines - Wo...Ifpma - Points to consider - biotherapeutics vs small molecule medicines - Wo...
Ifpma - Points to consider - biotherapeutics vs small molecule medicines - Wo...
 
Case studies in Strategy: Teva
Case studies in Strategy: TevaCase studies in Strategy: Teva
Case studies in Strategy: Teva
 
Reducing technical and regulatory uncertinty in biosimilar development
Reducing technical and regulatory uncertinty in biosimilar developmentReducing technical and regulatory uncertinty in biosimilar development
Reducing technical and regulatory uncertinty in biosimilar development
 
26. Dr. Nikolai Demidov - IMS Health
26. Dr. Nikolai Demidov - IMS Health26. Dr. Nikolai Demidov - IMS Health
26. Dr. Nikolai Demidov - IMS Health
 

Similar to Biosimilars-emerging market in india

Development of Biopharmaceuticals Industry in India
Development of Biopharmaceuticals Industry in IndiaDevelopment of Biopharmaceuticals Industry in India
Development of Biopharmaceuticals Industry in IndiaBhaswat Chakraborty
 
BIOSIMILARS.pptx
BIOSIMILARS.pptxBIOSIMILARS.pptx
BIOSIMILARS.pptxhrutujarane
 
Intended use of reference products & who international standards or reference...
Intended use of reference products & who international standards or reference...Intended use of reference products & who international standards or reference...
Intended use of reference products & who international standards or reference...National Institute of Biologics
 
Intended use of reference products & who international standards or reference...
Intended use of reference products & who international standards or reference...Intended use of reference products & who international standards or reference...
Intended use of reference products & who international standards or reference...National Institute of Biologics
 
applied strategic biosimilars success
applied strategic biosimilars successapplied strategic biosimilars success
applied strategic biosimilars successRichard Littlewood
 
applied strategic biosimilars success
applied strategic biosimilars successapplied strategic biosimilars success
applied strategic biosimilars successRichard Littlewood
 
Biological agents and it role in current era and future role
Biological agents and it role in current era and future roleBiological agents and it role in current era and future role
Biological agents and it role in current era and future roleHarsh shaH
 
applied strategic 10 years vision for biosimilars
applied strategic 10 years vision for biosimilarsapplied strategic 10 years vision for biosimilars
applied strategic 10 years vision for biosimilarsRichard Littlewood
 
concept of biosimilars
concept of biosimilarsconcept of biosimilars
concept of biosimilarskkoberoi
 
Pharmacovigilance Risk Management for Biosimilars
Pharmacovigilance Risk Management for BiosimilarsPharmacovigilance Risk Management for Biosimilars
Pharmacovigilance Risk Management for BiosimilarsCovance
 

Similar to Biosimilars-emerging market in india (20)

Biosimilars
BiosimilarsBiosimilars
Biosimilars
 
Biosimilars
BiosimilarsBiosimilars
Biosimilars
 
Development of Biopharmaceuticals Industry in India
Development of Biopharmaceuticals Industry in IndiaDevelopment of Biopharmaceuticals Industry in India
Development of Biopharmaceuticals Industry in India
 
Biosimilars
Biosimilars Biosimilars
Biosimilars
 
How dissimilarly similar are biosimilars
How dissimilarly similar are biosimilarsHow dissimilarly similar are biosimilars
How dissimilarly similar are biosimilars
 
How dissimilarly similar are biosimilars
How dissimilarly similar are biosimilarsHow dissimilarly similar are biosimilars
How dissimilarly similar are biosimilars
 
BIOSIMILARS.pptx
BIOSIMILARS.pptxBIOSIMILARS.pptx
BIOSIMILARS.pptx
 
Biosimilars 2020
Biosimilars 2020Biosimilars 2020
Biosimilars 2020
 
Intended use of reference products & who international standards or reference...
Intended use of reference products & who international standards or reference...Intended use of reference products & who international standards or reference...
Intended use of reference products & who international standards or reference...
 
Intended use of reference products & who international standards or reference...
Intended use of reference products & who international standards or reference...Intended use of reference products & who international standards or reference...
Intended use of reference products & who international standards or reference...
 
E0421024026
E0421024026E0421024026
E0421024026
 
Biosimilars.pptx
Biosimilars.pptxBiosimilars.pptx
Biosimilars.pptx
 
applied strategic biosimilars success
applied strategic biosimilars successapplied strategic biosimilars success
applied strategic biosimilars success
 
applied strategic biosimilars success
applied strategic biosimilars successapplied strategic biosimilars success
applied strategic biosimilars success
 
Biological agents and it role in current era and future role
Biological agents and it role in current era and future roleBiological agents and it role in current era and future role
Biological agents and it role in current era and future role
 
applied strategic 10 years vision for biosimilars
applied strategic 10 years vision for biosimilarsapplied strategic 10 years vision for biosimilars
applied strategic 10 years vision for biosimilars
 
Biosimilars
BiosimilarsBiosimilars
Biosimilars
 
concept of biosimilars
concept of biosimilarsconcept of biosimilars
concept of biosimilars
 
Pharmacovigilance Risk Management for Biosimilars
Pharmacovigilance Risk Management for BiosimilarsPharmacovigilance Risk Management for Biosimilars
Pharmacovigilance Risk Management for Biosimilars
 
Regulatory Requirement for the Product Approval of Biologics Ppt.pptx
Regulatory Requirement for the Product Approval of Biologics Ppt.pptxRegulatory Requirement for the Product Approval of Biologics Ppt.pptx
Regulatory Requirement for the Product Approval of Biologics Ppt.pptx
 

Recently uploaded

👉 Amritsar Call Girls 👉📞 8725944379 👉📞 Just📲 Call Ruhi Call Girl Near Me Amri...
👉 Amritsar Call Girls 👉📞 8725944379 👉📞 Just📲 Call Ruhi Call Girl Near Me Amri...👉 Amritsar Call Girls 👉📞 8725944379 👉📞 Just📲 Call Ruhi Call Girl Near Me Amri...
👉 Amritsar Call Girls 👉📞 8725944379 👉📞 Just📲 Call Ruhi Call Girl Near Me Amri...Sheetaleventcompany
 
💚Call Girls In Amritsar 💯Anvi 📲🔝8725944379🔝Amritsar Call Girl No💰Advance Cash...
💚Call Girls In Amritsar 💯Anvi 📲🔝8725944379🔝Amritsar Call Girl No💰Advance Cash...💚Call Girls In Amritsar 💯Anvi 📲🔝8725944379🔝Amritsar Call Girl No💰Advance Cash...
💚Call Girls In Amritsar 💯Anvi 📲🔝8725944379🔝Amritsar Call Girl No💰Advance Cash...Sheetaleventcompany
 
Control of Local Blood Flow: acute and chronic
Control of Local Blood Flow: acute and chronicControl of Local Blood Flow: acute and chronic
Control of Local Blood Flow: acute and chronicMedicoseAcademics
 
ANATOMY AND PHYSIOLOGY OF RESPIRATORY SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF RESPIRATORY SYSTEM.pptxANATOMY AND PHYSIOLOGY OF RESPIRATORY SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF RESPIRATORY SYSTEM.pptxSwetaba Besh
 
Jaipur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Jaipur No💰...
Jaipur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Jaipur No💰...Jaipur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Jaipur No💰...
Jaipur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Jaipur No💰...Sheetaleventcompany
 
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...Sheetaleventcompany
 
❤️Amritsar Escorts Service☎️9815674956☎️ Call Girl service in Amritsar☎️ Amri...
❤️Amritsar Escorts Service☎️9815674956☎️ Call Girl service in Amritsar☎️ Amri...❤️Amritsar Escorts Service☎️9815674956☎️ Call Girl service in Amritsar☎️ Amri...
❤️Amritsar Escorts Service☎️9815674956☎️ Call Girl service in Amritsar☎️ Amri...Sheetaleventcompany
 
Nagpur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Nagpur No💰...
Nagpur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Nagpur No💰...Nagpur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Nagpur No💰...
Nagpur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Nagpur No💰...Sheetaleventcompany
 
💰Call Girl In Bangalore☎️63788-78445💰 Call Girl service in Bangalore☎️Bangalo...
💰Call Girl In Bangalore☎️63788-78445💰 Call Girl service in Bangalore☎️Bangalo...💰Call Girl In Bangalore☎️63788-78445💰 Call Girl service in Bangalore☎️Bangalo...
💰Call Girl In Bangalore☎️63788-78445💰 Call Girl service in Bangalore☎️Bangalo...gragneelam30
 
👉 Chennai Sexy Aunty’s WhatsApp Number 👉📞 7427069034 👉📞 Just📲 Call Ruhi Colle...
👉 Chennai Sexy Aunty’s WhatsApp Number 👉📞 7427069034 👉📞 Just📲 Call Ruhi Colle...👉 Chennai Sexy Aunty’s WhatsApp Number 👉📞 7427069034 👉📞 Just📲 Call Ruhi Colle...
👉 Chennai Sexy Aunty’s WhatsApp Number 👉📞 7427069034 👉📞 Just📲 Call Ruhi Colle...rajnisinghkjn
 
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...gragneelam30
 
Kolkata Call Girls Naktala 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Girl Se...
Kolkata Call Girls Naktala  💯Call Us 🔝 8005736733 🔝 💃  Top Class Call Girl Se...Kolkata Call Girls Naktala  💯Call Us 🔝 8005736733 🔝 💃  Top Class Call Girl Se...
Kolkata Call Girls Naktala 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Girl Se...Namrata Singh
 
Ahmedabad Call Girls Book Now 9630942363 Top Class Ahmedabad Escort Service A...
Ahmedabad Call Girls Book Now 9630942363 Top Class Ahmedabad Escort Service A...Ahmedabad Call Girls Book Now 9630942363 Top Class Ahmedabad Escort Service A...
Ahmedabad Call Girls Book Now 9630942363 Top Class Ahmedabad Escort Service A...GENUINE ESCORT AGENCY
 
Call Girl In Indore 📞9235973566📞 Just📲 Call Inaaya Indore Call Girls Service ...
Call Girl In Indore 📞9235973566📞 Just📲 Call Inaaya Indore Call Girls Service ...Call Girl In Indore 📞9235973566📞 Just📲 Call Inaaya Indore Call Girls Service ...
Call Girl In Indore 📞9235973566📞 Just📲 Call Inaaya Indore Call Girls Service ...Sheetaleventcompany
 
💚Chandigarh Call Girls 💯Riya 📲🔝8868886958🔝Call Girls In Chandigarh No💰Advance...
💚Chandigarh Call Girls 💯Riya 📲🔝8868886958🔝Call Girls In Chandigarh No💰Advance...💚Chandigarh Call Girls 💯Riya 📲🔝8868886958🔝Call Girls In Chandigarh No💰Advance...
💚Chandigarh Call Girls 💯Riya 📲🔝8868886958🔝Call Girls In Chandigarh No💰Advance...Sheetaleventcompany
 
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service AvailableDipal Arora
 
Most Beautiful Call Girl in Chennai 7427069034 Contact on WhatsApp
Most Beautiful Call Girl in Chennai 7427069034 Contact on WhatsAppMost Beautiful Call Girl in Chennai 7427069034 Contact on WhatsApp
Most Beautiful Call Girl in Chennai 7427069034 Contact on WhatsAppjimmihoslasi
 
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...Sheetaleventcompany
 
Gastric Cancer: Сlinical Implementation of Artificial Intelligence, Synergeti...
Gastric Cancer: Сlinical Implementation of Artificial Intelligence, Synergeti...Gastric Cancer: Сlinical Implementation of Artificial Intelligence, Synergeti...
Gastric Cancer: Сlinical Implementation of Artificial Intelligence, Synergeti...Oleg Kshivets
 
Genuine Call Girls Hyderabad 9630942363 Book High Profile Call Girl in Hydera...
Genuine Call Girls Hyderabad 9630942363 Book High Profile Call Girl in Hydera...Genuine Call Girls Hyderabad 9630942363 Book High Profile Call Girl in Hydera...
Genuine Call Girls Hyderabad 9630942363 Book High Profile Call Girl in Hydera...GENUINE ESCORT AGENCY
 

Recently uploaded (20)

👉 Amritsar Call Girls 👉📞 8725944379 👉📞 Just📲 Call Ruhi Call Girl Near Me Amri...
👉 Amritsar Call Girls 👉📞 8725944379 👉📞 Just📲 Call Ruhi Call Girl Near Me Amri...👉 Amritsar Call Girls 👉📞 8725944379 👉📞 Just📲 Call Ruhi Call Girl Near Me Amri...
👉 Amritsar Call Girls 👉📞 8725944379 👉📞 Just📲 Call Ruhi Call Girl Near Me Amri...
 
💚Call Girls In Amritsar 💯Anvi 📲🔝8725944379🔝Amritsar Call Girl No💰Advance Cash...
💚Call Girls In Amritsar 💯Anvi 📲🔝8725944379🔝Amritsar Call Girl No💰Advance Cash...💚Call Girls In Amritsar 💯Anvi 📲🔝8725944379🔝Amritsar Call Girl No💰Advance Cash...
💚Call Girls In Amritsar 💯Anvi 📲🔝8725944379🔝Amritsar Call Girl No💰Advance Cash...
 
Control of Local Blood Flow: acute and chronic
Control of Local Blood Flow: acute and chronicControl of Local Blood Flow: acute and chronic
Control of Local Blood Flow: acute and chronic
 
ANATOMY AND PHYSIOLOGY OF RESPIRATORY SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF RESPIRATORY SYSTEM.pptxANATOMY AND PHYSIOLOGY OF RESPIRATORY SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF RESPIRATORY SYSTEM.pptx
 
Jaipur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Jaipur No💰...
Jaipur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Jaipur No💰...Jaipur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Jaipur No💰...
Jaipur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Jaipur No💰...
 
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
 
❤️Amritsar Escorts Service☎️9815674956☎️ Call Girl service in Amritsar☎️ Amri...
❤️Amritsar Escorts Service☎️9815674956☎️ Call Girl service in Amritsar☎️ Amri...❤️Amritsar Escorts Service☎️9815674956☎️ Call Girl service in Amritsar☎️ Amri...
❤️Amritsar Escorts Service☎️9815674956☎️ Call Girl service in Amritsar☎️ Amri...
 
Nagpur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Nagpur No💰...
Nagpur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Nagpur No💰...Nagpur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Nagpur No💰...
Nagpur Call Girl Service 📞9xx000xx09📞Just Call Divya📲 Call Girl In Nagpur No💰...
 
💰Call Girl In Bangalore☎️63788-78445💰 Call Girl service in Bangalore☎️Bangalo...
💰Call Girl In Bangalore☎️63788-78445💰 Call Girl service in Bangalore☎️Bangalo...💰Call Girl In Bangalore☎️63788-78445💰 Call Girl service in Bangalore☎️Bangalo...
💰Call Girl In Bangalore☎️63788-78445💰 Call Girl service in Bangalore☎️Bangalo...
 
👉 Chennai Sexy Aunty’s WhatsApp Number 👉📞 7427069034 👉📞 Just📲 Call Ruhi Colle...
👉 Chennai Sexy Aunty’s WhatsApp Number 👉📞 7427069034 👉📞 Just📲 Call Ruhi Colle...👉 Chennai Sexy Aunty’s WhatsApp Number 👉📞 7427069034 👉📞 Just📲 Call Ruhi Colle...
👉 Chennai Sexy Aunty’s WhatsApp Number 👉📞 7427069034 👉📞 Just📲 Call Ruhi Colle...
 
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
 
Kolkata Call Girls Naktala 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Girl Se...
Kolkata Call Girls Naktala  💯Call Us 🔝 8005736733 🔝 💃  Top Class Call Girl Se...Kolkata Call Girls Naktala  💯Call Us 🔝 8005736733 🔝 💃  Top Class Call Girl Se...
Kolkata Call Girls Naktala 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Girl Se...
 
Ahmedabad Call Girls Book Now 9630942363 Top Class Ahmedabad Escort Service A...
Ahmedabad Call Girls Book Now 9630942363 Top Class Ahmedabad Escort Service A...Ahmedabad Call Girls Book Now 9630942363 Top Class Ahmedabad Escort Service A...
Ahmedabad Call Girls Book Now 9630942363 Top Class Ahmedabad Escort Service A...
 
Call Girl In Indore 📞9235973566📞 Just📲 Call Inaaya Indore Call Girls Service ...
Call Girl In Indore 📞9235973566📞 Just📲 Call Inaaya Indore Call Girls Service ...Call Girl In Indore 📞9235973566📞 Just📲 Call Inaaya Indore Call Girls Service ...
Call Girl In Indore 📞9235973566📞 Just📲 Call Inaaya Indore Call Girls Service ...
 
💚Chandigarh Call Girls 💯Riya 📲🔝8868886958🔝Call Girls In Chandigarh No💰Advance...
💚Chandigarh Call Girls 💯Riya 📲🔝8868886958🔝Call Girls In Chandigarh No💰Advance...💚Chandigarh Call Girls 💯Riya 📲🔝8868886958🔝Call Girls In Chandigarh No💰Advance...
💚Chandigarh Call Girls 💯Riya 📲🔝8868886958🔝Call Girls In Chandigarh No💰Advance...
 
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
 
Most Beautiful Call Girl in Chennai 7427069034 Contact on WhatsApp
Most Beautiful Call Girl in Chennai 7427069034 Contact on WhatsAppMost Beautiful Call Girl in Chennai 7427069034 Contact on WhatsApp
Most Beautiful Call Girl in Chennai 7427069034 Contact on WhatsApp
 
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
 
Gastric Cancer: Сlinical Implementation of Artificial Intelligence, Synergeti...
Gastric Cancer: Сlinical Implementation of Artificial Intelligence, Synergeti...Gastric Cancer: Сlinical Implementation of Artificial Intelligence, Synergeti...
Gastric Cancer: Сlinical Implementation of Artificial Intelligence, Synergeti...
 
Genuine Call Girls Hyderabad 9630942363 Book High Profile Call Girl in Hydera...
Genuine Call Girls Hyderabad 9630942363 Book High Profile Call Girl in Hydera...Genuine Call Girls Hyderabad 9630942363 Book High Profile Call Girl in Hydera...
Genuine Call Girls Hyderabad 9630942363 Book High Profile Call Girl in Hydera...
 

Biosimilars-emerging market in india

  • 1. BIOSIMILARS EMERGING MARKET IN INDIA 1 Presentation by : U.PRUTHVIRAJ Roll.no.43 DOPM NIPER, MOHALI.
  • 2. INTRODUCTION  The Indian Pharmaceutical Industry has been a global leader in the cause of providing high quality affordable medicines to the world  The first generation of biological drugs, which have introduced many revolutionary treatments to life-threatening and rare illnesses, is currently facing patent expiration  The similar biologics industry, globally has been growing stupendously ,but still in its infancy 2
  • 3. • Therapeutic products typically derived from living systems and can also be produced by using biotechnological procedures. Biologic • A biological product produced by biotechnological methods and claimed to be “similar” in terms of safety, efficacy and quality to a reference biologic, which has been granted a marketing authorization in India Similar biologic 3 Officially approved subsequent version of innovators biologics after expiry of patent
  • 4. • „Biosimilars‟. Europe- EMEA • ‘Fallow- on Biologics’ US- FDA • „Subsequent Entry Biologics’ (SEBs). CANADA- BGTD 4
  • 6.  Global sales of biologics US $ 157 billions,2012  Global sales of biosimilars US $ 693 million,2012 6  Indian biologics market crossed US $ 3 billion,2011-12 Source : Global use of medicines outlook through 2016, IMS HEALTH-JULY2012 MARKET OVERVIEW Source : Ministry of external affairs,GOI Indian biosimilar market
  • 7. BIOLOGICS CORE THERAPY AREA OF BIOLOGICS MARKET ( $ US BILLION) Insulin 15.9 Anti-TNF 15.8 Oncology 12.5 EPO 7.6 Multiple sclerosis 7.3 CSF-G 5.0 Blood coagulation 3.1 Ocular antineovascular 2.0 Anti viral (no-HIV) 1.5 Others 16.5 7 Source : IMS HEALTH 2011
  • 9. Regulatory guidelines set by : INDIA DBT CDSCO U.S FDA EUROPEAN UNION EMEA 9
  • 10. EUROPE :THE FIRST MARKET  Today, the continent is the largest biosimilars market in the world with robust guidelines  EMEA( European Medicines Authority)  Reviews marketing authorization applications for biologics.  Award either positive or negative opinion based on evaluation of quality, safety and efficacy measures  After the product receives a positive opinion EC(EUROPEAN COMMISION) will grant marketing authorization valid for the European union.  Sandoz/Novartis, Stada, Hospira, Medice and Teva. 10 1st biosimilar - Omnitrope in 2006 for Somatropin(HGH)
  • 11. US MARKET  Largest Biologics market  The Patient Protection and Affordable Care Act , March 23rd 2010  Public Health Service Act  The U.S. FDA issued three draft guidance documents on Feb 9th ,2012 11
  • 13. COMPETENT AUTHORITIES INVOLVED IN APPROVAL PROCESS  RCGM(Review Committee on Genetic Manipulation)  Functions in Department of Biotechnology( DBT), Ministry of Science & Technology, Government of India(GOI)  Responsible for authorizing import & export for R&D and review of data up to preclinical evaluation  GEAC(Genetic Engineering appraisal Committee)  Functions under ministry of Environment & Forests  Responsible for review & approval of activities involving large-scale use of genetic engineered organisms & products there of in R&D , industrial production , environmental release and filed applications 13
  • 14.  CDSCO ( Central Drugs Standard Control Organization)  Headed by DCGI under Ministry of Health & Family Welfare  Responsible for clinical trail approval ,permission for marketing, manufacturing and grant of import& export license  State FDA works with CDSCO in each state & is responsible for issuance of license to manufacture similar biologics in India 14 Source : Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, GOI, 2012 GOI prepared this guidelines by referring EMEA guidelines, ICH guidelines, WHO guidelines
  • 15. Head-to-head characterization studies are required to compare the similar biologics and the reference biologic 15 GMP standard s Quality test pre- clinical testing to GLP clinical testing to GCP Post marketing safety APPROVAL PROCESS
  • 16. Continued.. 16 Reference biologic should be licensed in India In case, Reference biologic is not marketed in India, 4years market exclusivity given for innovator product . This period of 4 years may be reduced in case of National Healthcare Emergency
  • 17. FORCES SHAPING THE BIOSIMILARS MARKET Biologics patent expiries Rising Health Costs Burgeoning aging population and diseases like cancer, diabetes & R.I Price of biologics BIOSIMILARS MARKET 17 cost-effective alternatives to biologics reflects the growing demand for these speciality drugs
  • 18. 18
  • 19. HURDLES TECHNOLOGI AL BARRIERS INTERCHANG EABILITY UNCERTAIITI ES HIGHER GESTATION PERIOD HIGH COST TO DEVELOP 19 Average cost estimates range from US$80-120 million Reluctance from physicians to prescribe and use biosimilars Sophisticated technologies & processes Cost of Biosimilars products to consumers in emerging markets is still relatively high unlike small molecule generics that are at heavy discounts to originators.
  • 20. OPPORTUNITIES Oligopolistic market Less entry of Competitors Government initiatives to encourage Biosimilars. 20
  • 21. Companies should clear of their strategic relevance within the organization Portfolio fit Financial suitability Therapy areas-size of potential Synergies with the value chain THOSE LOOKING FOR JOINING BIOSIMILARS JOURNEY..
  • 23. INDIAN SCENARIO While almost all major Indian drug makers have outlined plans, identified products and set aside investment budgets to develop a robust product pipeline, some have even started rolling them into the market. 23 About 20 Indian companies entered into market Presently , there were about 15 epoetin, 8 G-CSF and 4 insulin biosimilars available
  • 24. INDIAN COMPANIES 24 The current biosimilars portfolio of Dr Reddy‟s Laboratories constitutes of filgrastim, peg-filgrastim, Rituximab and Darbepeotin alpha, which have commercial presence in 13 emerging countries. “Soon, I expect to see Dr Reddy’s 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 drugs for oncology in India by the end of this year. The company currently has a total of 10 proteins in different stages of development Reditux, a copy of Rituximab manufactured by Dr.Reddy‟s,has been available in India since 2007 1st biosimilar in INDIA
  • 25. Cipla are making huge investments in India and outside to acquire manufacturing facilities and potential product pipelines in the biosimilar segment 25  Wockhardt is among the early entrants and has developed insulin and analogues Recently opened a large biotech park in AURANGABAD, designed according to U.S & EMEA Standards Ranbaxy, Biocon, Shantha Biotech, Reliance Life Sciences, Panacea Biotec and Intas Biopharmaceuticals are also on the way
  • 26. 26 Ranbaxy holds 40% stake in Zenotech for marketing biosimilars Developing antibodies March 2012, Biocon and Pfizer had amicably concluded their alliance to commercialize Biocon‟s biosimilar versions of Insulin and Insulin analog products Co-develop and market the low-cost version of a biotech cancer medicine filgrastim (G-CSF) in North America and Europe
  • 27. 27
  • 28. CONCLUSION  The biosimilars market is in the nascent stage of the industry life cycle with limited market and product development experience. However, there is a significant market opportunity from patent expiries  High initial investments are still a major barrier for new entrants.  Collaborations among large pharmaceutical companies with financial capabilities and specialty biotech companies with technical expertise are expected  The strong integration of marketing and research and development skills is the key to success in the biosimilars market. 28 Companies need commitment, along with a well-charted strategic plan, investment and technical synergy because biosimilars is a long-term game, with many hurdles on the way.
  • 29. 29
  • 30.
  • 31. 31
  • 32. 32