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: What sets oncology biosimilars apart: Anticipating key challenges in the development landscape
With patent expirations encompassing numerous notable oncology biologics, opportunities for oncology biosimilar development are abundant.
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Blog: Oncology biosimilars on the rise: Key clinical development insights
As cancer treatment advances, biosimilars are becoming key players in oncology. While biologics have improved outcomes, their high costs remain a barrier. Biosimilars offer a more affordable alternative, closely replicating biologics whose patents have expired.
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Blog: Navigating post-market access and adoption of biosimilars across APAC
Post-market success of biosimilars depends on public health needs, reimbursement, and safety monitoring. Sponsors must navigate diverse regulatory and market landscapes. This analysis explores key post-market strategies in major APAC countries, including China, Japan, India, Singapore, and South Korea.
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Media article: The Evolving Cost-Benefit Landscape of Biosimilar Drug Development
The patent cliff for biologic medicines presents an opportunity for developers of biosimilars, but historically there are challenges too. But the landscape is changing.
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Blog: Making sense of the regulatory web governing biosimilars development across APAC
In recent years the Asia-Pacific (APAC) region has represented an area of growth in the biopharmaceutical sector, with expanding drug production and development — including in the area of 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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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.
Biosimilars case studies
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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.
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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.
