Biosimilars
Insight and thought leadership from our biosimilar experts
Making sense of the rapidly changing biosimilars landscape
Strategies for adapting and achieving optimal market access
The biosimilar landscape is rapidly shifting creating vast opportunities for developers. However, market insight and commercial strategy are the key to success. This whitepaper explores market trends in biologics, development impacts of new EMA and FDA regulatory shifts and how originator companies may respond to biosimilar competition.
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.
Evolving bioanalytical strategies in biosimilar development
Addressing new regulatory expectations and analytical paradigms
Recently, new regulatory publications and actions in the US and the EU have introduced changes to biosimilar approval requirements and development pathways. Learn more by reading our spotlight piece.
Blogs and media articles relating to biosimilars
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Blog: The differences between the US and EU biosimilar markets
Biosimilar uptake in the US market has, until now, stood in stark contrast to that in the EU, which has led the way in biosimilar approvals and use since 2006.
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Blog: Biosimilar development in ophthalmology
91黑料 experts Bart Chapman and Shanthi Sundaramoorthy answer common questions about ophthalmology studies, and those relating to biosimilars.
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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
91黑料's Centre for Biosimilar Drug Development
Learn more about how 91黑料's cross functional service offering can support your biosimilar drug development projects.