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Dr. Nigel A.S. HernandezPresident & Founder
Lessons Learned from Biosimilar Development in the Established European Marketplace
Business of Biosimilars & Biobetters 2011Seaport World Trade Center, Boston, MASeptember 2011
Keys Areas• Lessons Learned from Biosimilar Development in the Established
European Marketplace• European countries are furthest ahead in biosimilar development,
with Germany and the UK leading the way. • Hear what CenSRA takes into account when evaluating biosimilars• Estimate the effect a growing marketplace will have on biosimilar
pricing strategies• Discuss the long term benefits of creating biosimilars in a highly
regulated market, including the opportunity to easily move to less-regulated marketplaces
• Analyze regional-specific opportunities for commercializing biosimilars
Outlines • Introduction to CenSRA• Drug Development Economics• ‘The Birth’ of the Legal Framework for Biosimilar Medicines in
the European Union • When Can Biosimilar Medicines Applications Take Place? • What are the Data Requirements? • INN/International Non-proprietary Name • Post-Authorization • Biosimilar Medicines in the Market Place • CenSRA Vision
Acronyms• EU European Union• EMEA (EMA) European Medicines Agency• CHMP Committee for Medicinal Products for Human Use• EC European Commission• WHO World Health Organization• MS Member State• MAA Marketing Authorization Application• MAH Marketing Authorization Holder• DE Data Exclusivity• ME Market Exclusivity• INN International Non-Proprietary Name• ADR Adverse Drug Reaction• RMP Risk Management Plan• PASS Post Authorization Safety Study
Speaker BiographyEXPERIENCE:• Founder and Chairman, Center for the Study of Regulatory Affairs• Chief Regulatory Science, Quality & Food Safety Officer, GloboFruit, LLC• Chief Regulatory Science Officer, GMP Regulatory Science Partners• Academic Appointments: University of Maryland University College,
Previous: West Virginia University & Northeastern University
NORTHEASTERN UNIVERSITY• Doctor of International Biomedical & Food Regulatory Science.• MSc., Regulatory Affairs for Drugs, Biologics & Medical Devices• Masters Certificate, International Biopharmaceutical Regulatory Affairs• Masters Certificate, Medical Devices Regulatory Affairs (US, EU, Japan)
BOSTON UNIVERSITY• Master of Science, Advertising
EDINBURGH BUSINESS SCHOOL• Master of Business Administration
Introduction• CenSRA - The Center for the Study of Regulatory
Affairs addresses regulatory affairs within each category of regulated agents: drugs, biologics, medical devices and combination products.
• An innovative regulatory center that will serve all constituencies in the medical products community –industry, regulators, researchers, clinicians, patients, associations and academic centers – to share knowledge to accelerate the regulatory paradigms and best practices for the discovery and commercialization of new medical products for improving patients lives and outcomes.
• Competitive and market changes• Turnover • New scientific knowledge and discoveries • Regulatory changes/ new standards • New disease knowledge • Potential indications• Financial & Capital Markets
Legislation has publicly stated goals, but• Are they well resourced?• Are they well planned? • Are they independent?• Are the interests aligned?• Are they informed by all
relevant stakeholders?• Are they free of political or
Nomenclature: Same INNDecision lies with RegulatorsWith regard to the nomenclature of biosimilars, we do not endorse the idea that any difference in glycosylation automatically leads to a different INN. We have serious doubts that this stance could be scientifically justified. We are also concerned that the WHO is promoting a double-standard policy on biosimilars.
G.Lalis/Director General EC -Statement on WHO INN Policy at EGA Annual Conference Paris 2 Junehttp://www.egagenerics.com/doc/GLalis_speech_egaconf2008.pdf
G. Lalis/Director General ECon Pharmacovigilance for BiosimilarsEGA Annual Conference Paris 6/08
Furthermore we have written to Member States' regulatory authorities to take necessary measures to ensure • a method to link suspected adverse reaction
reports to specific products (such as a unique product identifier) and
• to ensure that prescribing doctors know which glycoprotein has been given to their patient.
Biosimilar Drugs in the EU Market• National pricing approvals and reimbursement
have been agreed without any major barriers• Market in-roads are made• Patients and healthcare professionals are• catching up• But scare tactics still ongoing by certain
Message from the European Commission• ………….’we are confident that if a
product goes through all the steps and meets all the requirements and gets at the end an approval through a Commission Decision, it means that this product is as safe and efficacious as any other product authorised by the European Commission in the EU’.
Global Development for Biosimilars• Streamlining the development process• Avoids repetition of unnecessary trials• Increases access through affordable medicines• Increases competition
– Market competition from biosimilar drugs willdrive the biotechnology industry to do what itdoes best – discover new drugs that enhance,sustain, and save lives.