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 changing regulatory requirements for biosimilar drug development: more nuanced than they initially appear
Biosimilars are rising in importance in modern healthcare, offering cost-effective alternatives to biologic medicines and improving patient access to life-saving therapies. However, the regulatory landscape governing their development has been anything but static.
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Blog: Driving biosimilar adoption in APAC
To succeed in APAC, biosimilar sponsors must build patient and provider trust. This blog explores adoption barriers and strategies for outreach and education to boost biosimilar uptake.
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Media article: Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
As patent expirations in oncology biologics increase, what are the opportunities, regulatory pathways and challenges this presents for developers? Publication: Citeline Generics Bulletin
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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. Publication: Drug Discovery & Development Magazine
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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.
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
Despite effective treatments, osteoporosis still needs better, affordable options. A sponsor ran a 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.
