Biosimilars
Insight and thought leadership from our biosimilar experts
The future of oncology biosimilars: Considerations for development through 2040
As patents for over 100 biologics—mainly in oncology—expire, biosimilars have a growing opportunity to expand access and enter established and underserved markets. This whitepaper explores the evolving oncology biosimilars landscape, regulatory strategies, challenges to market access, and innovations in post-market monitoring.
Blogs and media articles relating to biosimilars
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Media article: The U.S. biosimilars market: Shaking the “laggard” label
An article by Katya Svoboda and Bob Swann which explores the fundamental differences in the regulatory processes and the market dynamics of the US and the EU which account for much of the discrepancy in the uptake of biosimilars.
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Media article: Trends in Biosimilar Market Access
A thought leadership article authored by Jenny Lee and Gene Chieh, investigating how biosimilars have gained momentum in a growing number of markets.
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Media article: Embracing Biosimilars
Ioannis Katsoulis, Axel Svedbom, Larushka Mellor and Rjan Kerborg consider trends and strategies to drive uptake of biosimilars in the UK.
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Blog: Lean and mean biosimilar trial design
Biosimilar clinical trials shows that strategic planning and a few simple tactics can increase return on investment and expedite time to market for biosimilars
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Blog: FDA Draft Guidance 2017 on Interchangeability of a Biosimilar
The FDA draft guidance, issued in January 2017, is the first recommendation the FDA has issued on interchangeability.
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Blog: Breaking into the Biosimilars Market: Opportunities & Challenges for Sponsors
Seven out of the 10 best selling drugs in 2015 were biologics.
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Blog: Biosimilar Development in Ophthalmology
ICON experts Bart Chapman and Shanthi Sundaramoorthy answer common questions about ophthalmology studies, and those relating to biosimilars.
ICON's Centre for Biosimilar Drug Development
Learn more about how ICON's cross functional service offering can support your biosimilar drug development projects.