This document provides an overview of biosimilars. It discusses that biosimilars are similar versions of biologic drugs that are set to lose patent protection. This presents both opportunities to make cheaper biologics to increase access, as well as regulatory challenges to demonstrate similarity. The global biosimilars market is growing, driven by both developed and emerging markets. India is emerging as a key player, with companies developing biosimilars for both domestic and export markets. However, hurdles remain around establishing clear regulatory pathways and demonstrating similarity to reference biologics.
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
February 7, 2017
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.
This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forward
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
Biosimilars are biological generics drugs.They undergo a rigorous evaluation to get approved.How to prove biosimilariy from analytical comparability is explained using a recently approved US FDA bio-similar monoclonal antibody.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
February 7, 2017
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.
This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forward
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
Biosimilars are biological generics drugs.They undergo a rigorous evaluation to get approved.How to prove biosimilariy from analytical comparability is explained using a recently approved US FDA bio-similar monoclonal antibody.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
Biosimilars or follow-on-biologics are highly similar versions of reference biologics derived from living organisms such as plants and animals. The development of biosimilars and validation with reference biologics play a significant role in the commercialization of biosimilars. Economic pricing of biosimilars, ease in development and a quick approval process are some key driving factors that drive the growth of this market. Effective and timely formulated regulations facilitate the viability and balance between original and biosimilar products. Moreover, a favorable regulatory environment and the establishment of IPR protections are factors that boost the market growth.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion on biologics, including an explanation of the high level of precision that is required to produce a consistent biological product each time.
● Discussion on the growing interest in biosimilars, followed by what we can learn from Europe’s experience.
● Health Canada’s position on biosimilars, discussion on key issues surrounding biosimilars relevant to the Canadian market.
● The importance of patient safety and patient choice.
View the video: https://youtu.be/h3Ap6HoiSC8
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
Biogenerics – Evolving Risks and Opportunities_M Staples_Mar08m_a_staples
Biogenerics – Evolving Risks and Opportunities for Biopharmaceutical, Generic, andContract Manufacturers
Presented at 2008 BioPharma Outsourcing, Boston
A generic medicine contains the same active ingredient as the originators product on which it is based and as such is interchangeable with this originators. It offers the same high quality and efficacy, together with affordability. In theory, dosage, indications, cons-indications, side effects and safety guarantees are the same.
The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar medicine was approved by the European Commission in 2006.
Biologics (eg, vaccines, blood and blood components, somatic cells, gene therapy, tissues, therapeutic proteins) are regulated by the US Food and Drug Administration (FDA). Biologics/Biosimilars/Biobetters are widely used to diagnose, prevent, treat, and cure diseases and medical conditions.
Naveen Kumar Singh received his B.Sc. in Biotechnology (2007) at University of Pune (Pune, India), M.Sc. in Biotechnology (2009) at Jaipur National University (Jaipur, India), and Ph.D. in Biochemical Engineering (2016) at Jacobs University Bremen (Bremen, Germany).
During his Ph.D., Naveen worked under the supervision of Prof. Marcelo Fernández-Lahore. His research dealt with designing experiments for developing fiber-based and cryogel-based adsorbents for capturing large therapeutic biomolecules (proteins, plasmids, and monoclonal antibodies). He had successfully evaluated the in-house fiber- and cryogel-based chromatographic adsorbents with the commercially available adsorbents and the in-house adsorbents had shown similar or higher productivities compared to the commercial adsorbents.
In February 2017, Naveen joined the group of Prof. Merlin L. Bruening in the Department of Chemical and Biomolecular Engineering at the University of Notre Dame as a Postdoctoral Research Associate. His current research focuses on developing novel bioseparation processes by introducing polyelectrolyte multilayer films onto membranes/monoliths for the purification of biotherapeutics like monoclonal antibodies.
Publications:
N. K. Singh, et al, “Preparation and Characterization of Grafted Cellulosic Fibers and their Applications in Protein Purification“, Sep. Purif. Technol., 143 (2015) pp. 177–183. https://www.sciencedirect.com/science/article/pii/S1383586615000714
N. K. Singh, et al, “Direct Capture of His6-tagged Proteins Using Megaporous Cryogels Developed for Metal-ion Affinity Chromatography“, inAffinity Chromatography (Ed.: S. Reichelt), Spinger, New York, USA, Methods in Molecular Biology, 1286 (2015) pp. 201–212. http://link.springer.com/protocol/10.1007/978-1-4939-2447-9_16
N. K. Singh, et al, “Gamma ray mediated functionalization of monolithic cryogels for macro-biomolecule purification“, N. Biotechnol., 31, Supplement (2014) pp. S127. http://www.sciencedirect.com/science/article/pii/S1871678414019906
N. K. Singh, et al, “High capacity cryogel-type adsorbents for protein purification“, J. Chromatogr. A, 1355 (2014) pp. 143–148. https://www.sciencedirect.com/science/article/pii/S0021967314008899
N. S. Bibi, N. K. Singh, et al, “Synthesis and performance of megaporous immobilized metal-ion affinity cryogels for recombinant protein capture and purification“, J. Chromatogr. A, 1272 (2013) pp. 145–149. https://www.sciencedirect.com/science/article/pii/S0021967312017670
Blog articles:
What are cryogels? https://www.biochemadda.com/cryogels-monolith-ion-exchange-affinity-chromatography/
Biosimilars or follow-on-biologics are highly similar versions of reference biologics derived from living organisms such as plants and animals. The development of biosimilars and validation with reference biologics play a significant role in the commercialization of biosimilars. Economic pricing of biosimilars, ease in development and a quick approval process are some key driving factors that drive the growth of this market. Effective and timely formulated regulations facilitate the viability and balance between original and biosimilar products. Moreover, a favorable regulatory environment and the establishment of IPR protections are factors that boost the market growth.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion on biologics, including an explanation of the high level of precision that is required to produce a consistent biological product each time.
● Discussion on the growing interest in biosimilars, followed by what we can learn from Europe’s experience.
● Health Canada’s position on biosimilars, discussion on key issues surrounding biosimilars relevant to the Canadian market.
● The importance of patient safety and patient choice.
View the video: https://youtu.be/h3Ap6HoiSC8
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
Biogenerics – Evolving Risks and Opportunities_M Staples_Mar08m_a_staples
Biogenerics – Evolving Risks and Opportunities for Biopharmaceutical, Generic, andContract Manufacturers
Presented at 2008 BioPharma Outsourcing, Boston
A generic medicine contains the same active ingredient as the originators product on which it is based and as such is interchangeable with this originators. It offers the same high quality and efficacy, together with affordability. In theory, dosage, indications, cons-indications, side effects and safety guarantees are the same.
The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar medicine was approved by the European Commission in 2006.
Biologics (eg, vaccines, blood and blood components, somatic cells, gene therapy, tissues, therapeutic proteins) are regulated by the US Food and Drug Administration (FDA). Biologics/Biosimilars/Biobetters are widely used to diagnose, prevent, treat, and cure diseases and medical conditions.
Naveen Kumar Singh received his B.Sc. in Biotechnology (2007) at University of Pune (Pune, India), M.Sc. in Biotechnology (2009) at Jaipur National University (Jaipur, India), and Ph.D. in Biochemical Engineering (2016) at Jacobs University Bremen (Bremen, Germany).
During his Ph.D., Naveen worked under the supervision of Prof. Marcelo Fernández-Lahore. His research dealt with designing experiments for developing fiber-based and cryogel-based adsorbents for capturing large therapeutic biomolecules (proteins, plasmids, and monoclonal antibodies). He had successfully evaluated the in-house fiber- and cryogel-based chromatographic adsorbents with the commercially available adsorbents and the in-house adsorbents had shown similar or higher productivities compared to the commercial adsorbents.
In February 2017, Naveen joined the group of Prof. Merlin L. Bruening in the Department of Chemical and Biomolecular Engineering at the University of Notre Dame as a Postdoctoral Research Associate. His current research focuses on developing novel bioseparation processes by introducing polyelectrolyte multilayer films onto membranes/monoliths for the purification of biotherapeutics like monoclonal antibodies.
Publications:
N. K. Singh, et al, “Preparation and Characterization of Grafted Cellulosic Fibers and their Applications in Protein Purification“, Sep. Purif. Technol., 143 (2015) pp. 177–183. https://www.sciencedirect.com/science/article/pii/S1383586615000714
N. K. Singh, et al, “Direct Capture of His6-tagged Proteins Using Megaporous Cryogels Developed for Metal-ion Affinity Chromatography“, inAffinity Chromatography (Ed.: S. Reichelt), Spinger, New York, USA, Methods in Molecular Biology, 1286 (2015) pp. 201–212. http://link.springer.com/protocol/10.1007/978-1-4939-2447-9_16
N. K. Singh, et al, “Gamma ray mediated functionalization of monolithic cryogels for macro-biomolecule purification“, N. Biotechnol., 31, Supplement (2014) pp. S127. http://www.sciencedirect.com/science/article/pii/S1871678414019906
N. K. Singh, et al, “High capacity cryogel-type adsorbents for protein purification“, J. Chromatogr. A, 1355 (2014) pp. 143–148. https://www.sciencedirect.com/science/article/pii/S0021967314008899
N. S. Bibi, N. K. Singh, et al, “Synthesis and performance of megaporous immobilized metal-ion affinity cryogels for recombinant protein capture and purification“, J. Chromatogr. A, 1272 (2013) pp. 145–149. https://www.sciencedirect.com/science/article/pii/S0021967312017670
Blog articles:
What are cryogels? https://www.biochemadda.com/cryogels-monolith-ion-exchange-affinity-chromatography/
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.
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.
1. Biosimilars
A Presentation
By
ANSHUL SHARMA
Graduate Research Scholar
Deptt. Of Biochemical Engg & Biotechnology,
Indian Institute of Technology, Delhi
2. Biosimilars
• Coined by EMA (European Medicine Agency)
• Bio-betters
• Similar Biological Products (SBP)
• Follow-on bioproducts
• “Generics of Bio-pharmaceutical Industry”
• Caution : Not alternative biologics
3. The Fuzz….
Massive Patent expiration for Blockbuster Innovator
biologics by 2016 (~ $25bn Market Cap)
Eg. Herceptin, Rituxan
Increased pressure of affordability of biologics on sales of
companies and health budgets of govt.
Cerezyme (Gaucher Disease) : $200000 per patient per annum
Herceptin (Breast Cancer ) : $30000 per patient per annum
•Make cheaper biologics
•Remove monopolies and bring competitiveness in market
4. Loss of Patent Protection
AROUND $25bn Market
Source : Analysis Group Health Care Consulting Bulletin (Fall/Winter 2010)
5. Biosimilars As A Healthcare Concept
Layers of “The Concept” – ( Interlocked Layers )
Scientific Layer
• Concept of similarity in term of bio-characterization, potency, safety & effect w.r.t
innovator molecule
• Predictable PK & PD based on data for reference compound
Regulatory Layer
• Faster & Easier approval route
• Early market entry,
• Reduced Clinical trial requirements (extrapolation on basis of data available for the
innovator molecule )
Market and Social Layer
• Established & Larger Market Base and distribution channels
• Cost- Demand trade off,
• Increased Profit Margins for sponsors
• Affordability
6. WHERE DOES THIS DIFFERENCE COMES FROM ?
Sources of variation between manufacture of innovator biopharmaceutical and Biosimilars
Source: Misra M , Biosimilars: current perspectives and future implications, Indian J Pharmacol..,2012 Jan;44(1):12-4.
8. Global Market
Source: Article on: Biosimilar Market Posts Steady Gains ,Genetic Engineering &
Biotechnology News dated Jun 15, 2012 (Vol. 32, No. 12)
Original : BCC Research
9. Why Developed Market like US need Biosimilars ?
• Load of existing biologics on the
National Health Insurance Budget
Biological Price Competition and Innovation Act, 2009 (BPCI)
Impact :
Medicaid Tax Deficit Total expenditure
spending (biologics )
-$ 4bn
(2013)
-$6.6bn
(2013)
Source: Congressional Budget Office Estimate, 2008 -$25 bn
(2018)
10. US FDA
• Lag behind EMA on Approval and Guidelines on Biosimilars
•Obama Administration :
Decrease BPCI set data exclusivity limit to 7 years from existing 12
years in 2012-13 FY. (SAVING OF $4 billion over 10 years)
•Opposition from Drug developers (Issue in Supreme Court)
11. List of Biosimilars (as of 9/11/2012)
Date of authorisation /
Brand Name Active substance Status
refusal
Abseamed epoetin alfa 28/08/2007 Authorised
Alpheon recombinant human interferon alfa-2a 22/10/2007 Refused
Binocrit epoetin alfa 28/08/2007 Authorised
Biograstim filgrastim 15/09/2008 Authorised
Epoetin Alfa Hexal epoetin alfa 28/08/2007 Authorised
Filgrastim Hexal filgrastim 06/02/2009 Authorised
Filgrastim ratiopharm filgrastim 15/09/2008 Withdrawn
Nivestim filgrastim 08/06/2010 Authorised
Omnitrope somatropin 12/04/2006 Authorised
Ratiograstim filgrastim 15/09/2008 Authorised
Retacrit epoetin zeta 18/12/2007 Authorised
Silapo epoetin zeta 18/12/2007 Authorised
Tevagrastim filgrastim 15/09/2008 Authorised
Valtropin somatropin 24/04/2006 Withdrawn
Zarzio filgrastim 06/02/2009 Authorised
Source : EMA website
12. Lets come back to India
• Emerging Biopharma hub , Robust Manufacturing
Base
• Itself a big market, semi-regulated
(Easier market entry + High demand = PROFITS)
• Regulation
Central Drug Standard Control Organization CDSCO
& DBT recently drafted Pre-market Regulatory
Compliances : Guidelines on Similar Biologics (2012)
13. Indian Players in Biosimilars
• Trends
• Target Markets : Domestic + Developed Market ( as Contract
Manufacturers)
• Stronger Acquisition Strategy : Capacity Building for production
• Aiming for Regulated Markets like US and EU also
• Strong Response to Tap Opportunity from:
Biocon, Dr. Reddy’s Lab., Wockhardt, Cipla Pharmaceuticals
• Partnerships
Merck Serono Enters Biosimilar Segment in Deal with Dr. Reddy's, Jun
7, 2012, GENNewsHighlights (A WIN-WIN
SITUATION)
14. Indian Players
Company Biosimilars in Pipeline/Market Remarks Source
Wanted to tap $17bn out of Company
Biocon RHI, mABs projected $20bn Insulin Annual Report
Biosimilars Market (2020) FY2011-12
Filgrastim , Rituximab , Darbepotin (Market) Focus on EU Market,
Company
Dr. Reddy’s Lab. Merck –Reddy Deal
Website
G-CSF
Company
Interferon alpha, beta , EPO, FSH, G-CSF, Subsidiary in Ireland
Reliance Life Sciences Website
r-hCG , tPA Focus on EU market
Company
Lupin Releasing 2 by end of year - Website
Company
Wosulin(Market)
Wockhardt Early Enterant in Biosimilars Website
10 in Piipeline
Company
Heavy acquisition in China and
Cipla Developing Website
Malaysia
15. Hurdles
• Proper Regulatory structure not in place yet.
• A competitive edge to original manufacturer
(good knowledge base for manufacturing a Biosimilars based on
innovator biologic production)
• Proof of Similarity and comparability to innovator product
requires very hectic characterization.
(LOT OF ANALYSIS COMPARED TO GENERICS )
A lot of Analytic Techniques required for validation ( IEX
(charge), RPLC, SEC, AXC , CE etc )
16. What can be done ?
• Post Approval Risk Plan
- Strong communication between front end of healthcare system
(Doctors) to the manufacturer and regulatory authorities.
- Continuation of post approval trials
• Option between a well established (but costly) biologics and A
newly introduced Biosimilars should be left to patient’s will.
• Streamlined regulatory pathways for global platform