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
-
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.
-
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
-
Blog: FDA Draft Guidance 2017 on Interchangeability of a Biosimilar
The FDA draft guidance, issued in January 2017, is the first recommendation the FDA has issued on interchangeability.
-
Blog: Breaking into the Biosimilars Market: Opportunities & Challenges for Sponsors
Seven out of the 10 best selling drugs in 2015 were biologics.
-
Blog: Biosimilar Development in Ophthalmology
ICON experts Bart Chapman and Shanthi Sundaramoorthy answer common questions about ophthalmology studies, and those relating to biosimilars.