This report assesses the potential role of biosimilars in improving access and affordability for orphan biologic drugs in Europe. It analyzes the upcoming loss of exclusivity for several orphan biologics and the challenges biosimilar developers face, including limited patient populations, complex manufacturing, and regulatory uncertainty. The report highlights significant variation in biosimilar uptake across European markets and discusses pricing, tendering, and policy dynamics. It concludes that while biosimilars could generate savings and expand access, success will depend on supportive regulatory frameworks, stakeholder confidence, and sustainable market incentives.

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