Workshop on Improving Biosimilar Regulations and Facilitating Access, Geneva

Biologic medicines have transformed the treatment of cancer, autoimmune disorders, diabetes, and other life-threatening diseases. However, their high cost continues to limit patient access, particularly in low- and middle-income countries. Biosimilars with highly similar versions of reference biologics offer a strategic solution to this challenge by enabling more affordable therapies without compromising quality, safety, or efficacy. Yet, the pathway for biosimilar development and approval remains complex, requiring advanced manufacturing capacity, rigorous analytical tools, and harmonised regulatory standards.

Recognising the challenges and opportunities, the Third World Network (TWN) convened a “Workshop on Improving Biosimilar Regulation & Facilitating Access” at Appart’City Collection, Genève Aéroport Ferney Voltaire, Geneva, on 11–12 September 2025 in Geneva, Switzerland.

Objectives

• Explore the growing opportunities within the biosimilar industry and unpack access challenges in developing countries
• Understand the evolving regulatory landscape for biosimilars and implications for the biosimilar industry and patient access.
• Evaluate critical  analytical considerations, the importance of PK/PD studies, and moving beyond clinical efficacy studies in the biosimilar regulatory process
• Facilitate collaborations among regulators from key developing countries, global experts, civil society representatives, industry leaders, and access advocacy groups to share insights on the latest advancements in biosimilar regulations.

The two-day workshop addressed critical issues surrounding the regulation of biosimilars. The workshop brought together an international panel of regulators, technical experts, policymakers, academics, and civil society representatives. It had participation from regulators in the African Medicine Agency, Bangladesh, Brazil, Argentina, Colombia, Chile, Egypt, Ghana, Malaysia, India, Indonesia, Kenya, Philippines, South Africa, Thailand and Vietnam. In addition to regulators, the workshop had representation from Utrecht University (The Netherlands), Leiden University Medical Centre (The Netherlands), Biocon Biologics, Sandoz, Samsung Bioepis, and the Finnish Medicines Agency (Fimea).