Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
- Published: April 2011
- Region: Europe, United States
It was supposed to be the “epoch of biosimilars”, or drugs that copied existing biologics but had the potential to be more cost-effective. Yet five years later, biosimilars have failed to reach their forecasted potential of $16.4 billion in sales this year, falling short to just $235 million in 2010.
The pitfalls—everything from cost and unfavorable US legislation to a lack of interchangeability and physician resistance—have led some in the industry to ring the death knell. Yet according to others, the market remains alluring, predominantly because it represents life-changing medicine and the future of healthcare.
Cast against European and particularly German experiences, Gauging the Biosimilar Effect: will the market boom or bust? looks at the current state-of-play for biosimilars. The report, based on 16 industry interviews, examines the drivers and resistors to the still-unproven biosimilars market. The report moves from a general discussion of biosimilars to an explanation why they proved immediately popular in Germany. Market drivers—patent expiry, developing markets and costs savings—are reflected against the roadblocks, including high barriers to entry, lack of substitution, repressive US legislation and the physicians’ reluctance to engage. Finally, the report reviews the responses of both innovator and biosimilar companies, as well as their strategies for future success.
- Insight from 16 industry leaders from Europe, the US and Canada
- Unique insight into the German biosimilars market
- Recommendations of how the industry can move forward
Key Questions Asked
- What are the drivers and resistors of biosimilar uptake?
- Why was Germany the most successful market for biosimilars?
- What strategies should biosimilar manufacturers do to increase uptake?
- How should the branded industry respond?
- How will the biosimilars industry evolve and what forces will shape it?
Who Would Benefit From This Report?
- Executive Management
- Sales and Marketing Executives
- Pricing and Reimbursement Teams
- Medical and Scientific Affairs Professionals
- Pharmaceutical Consultants
- Strategic Planning Executives
- Clinical Development Professionals
- Regulatory and Government Affairs Managers
Expert Views Include:
- Gillian Woollett, Vice President, Avalere Health
- Louis-Christian Clauss, Senior Consultant, Hisut SA and Atheln Biomed
- Peter Pitts, President and Cofounder, Center for Medicine in the Public Interest
- Markus Hauser, Director Strategic Commercial Effectiveness, Biogen Idec
- Alex Kanarek, Senior Consultant, BioProcess Technology Consultants Inc.
- Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting
- Andrew Bourgoin, Pharmaceutical Research Analyst, Thomson Reuters
- Andrew Merron, Director, Biosimilars Advisory Service & Oncology, Decision Resources
- Ronald Rader, President, Biotechnology Information Institute
- Steven Grossman, Consultant, Public Policy and FDA
- Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc.
- Kristie Kuhl, Senior Vice President, Makovsky & Co.
- Clifford Mintz, Management Consultant
- Dimitrios Papadopoulos, Commercial Executive in the Pharmaceutical Industry
- Regina Au, Strategic Marketing Consultant, BioMarketing Insight
- Michael Castagna, Executive Director, Immunoscience Division, Bristol-Myers Squibb
Key Report Features
- Comprehensive and up-to-date overview of the biosimilars market
- Insight into the resistors and drivers to biosimilar uptake
- Strategies on how to improve biosimilar spending
- Discussion of how the branded industry should respond to defend market share SHOW LESS READ MORE >
- The Biologics Market
- Patent Landscape
- Innovation comes at a cost
- Regulatory Overview
The Biosimilars Market
- This is not a generics market
- EU’s biosimilars market
- Biosimilar uptake in the EU
- Initial uptake was rapid in Germany
- Reference Pricing System
- Reimbursement system
- Pre-defined quotas
Market Drivers and Resistors
- Market Drivers
- Cost savings
- Patent expiry
- Fierce competition
- Growth of developing markets
- Expanding uses of drugs
- Market Resistors
- High barriers to entry
- Technical challenges
- Clinical challenges
- Lack of substitution and interchangeability
- Wholesale switching
- Therapeutic substitution
- Unfavorable biosimilars laws in the US
- Period of market exclusivity
- Data sharing
- Reluctant physicians
- Lack of physician and patient education
- Outright opposition to biosimilars
- Lack of incentives
- Patient and public misperception
- Assignment of the International Nonproprietary Name (INN)
Response from innovator companies
- Reduce the price of the innovator drug
- Form a biosimilars division
- Partner with a biosimilars company
- Rely on their resources
- Develop innovative second-generation drugs
Response from biosimilars companies
- Make a capital investment
- Develop competitive marketing strategies
- Early entry strategies
- Direct marketing
- Emerging markets
- Choice of target
- Form partnerships
- Have a legal strategy in place