Biosimilars
Insight and thought leadership from our biosimilar experts
The next era of oncology biosimilars
Oncology biosimilars have already helped expand access to established biologic treatments while supporting more sustainable healthcare spending. In this podcast, ICON experts discuss how scientific innovation, evolving standards of care and changing market dynamics are influencing the next generation of oncology biosimilars.
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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Media article: PM360 Think Tank – biosimilar rulings impact
As biosimilar pathways become faster and less costly, innovators need stronger differentiation, patient support and market access strategies.
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Blog: Oncology biosimilars in Europe
Europe’s oncology biosimilar market is evolving. What changes are driving this, what are the challenges and what market dynamics should developers consider.
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Media article: How evolving biosimilar guidance is reshaping bioanalytical strategy
This article discusses how regulatory change makes bioanalytical testing, such as CMC analysis, as well as PK/PD studies, more important for getting regulatory approval.
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Blog: Evolving bioanalytical strategies in the field of biosimilar drug development
This blog explores the latest regulatory shifts and their impact on biosimilar development, evidence generation, and market access.
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Media article: The next wave of biosimilars: why hematology is a high-stakes opportunity
A confluence of patent expiries and rising healthcare costs are accelerating both interest and investment in biosimilars across the world. Nowhere is this more apparent than in hematology.
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Media article: Biosimilar success in an evolving landscape: development considerations for staying competitive
Discover how developers can stay ahead and position their programs for more efficient market entry, read the article by ICON’s Head of the Centre for Biosimilar Drug Development
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Media article: Faster doesn’t mean easier: development impacts of a new biosimilar regulatory landscape
Regulatory authorities have made it clear that streamlining biosimilar development is a priority, following the example of the EMA and FDA in reducing the requirements for comparative efficacy studies. Read this article to understand the recent changes and their impact.
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Blog: Streamlining the biosimilars playbook
In this blog, we explore two major March 2026 regulatory changes from the European Medical Agency (EMA) and U.S. Food and Drug Administration (FDA) and their potential ramifications.
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ICON's Centre for Biosimilar Drug Development
Learn more about how ICON's cross functional service offering can support your biosimilar drug development projects.
Biosimilars case studies
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Case study: Recruitment success in a challenging phase 1 osteoporosis biosimilar study
Successful 3-arm, double-blind study on a denosumab biosimilar in 225 healthy men over 10 months at two ICON sites.
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Case study: Optimising biosimilar development
ICON’s proactivity in risk mitigation, commitment to the study, project planning and communication contributed significantly to the ultimate success of the study.
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Case study: Elevating biopharma R&D
A biopharma partner required support with an FSP model across multiple service areas, seamlessly integrated with an existing FSO partnership.
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Case study: Multinational phase 1 biosimilar study
ICON conducted a multinational biosimilar phase 1 study for multiple sclerosis (MS). This trial was performed under high regulatory scrutiny and challenging pandemic conditions, with increased dosing targets requiring additional site activation.
