Workshop on a tailored clinical approach in biosimilar development

• Date:
  Monday, 22 September 2025 , 09:00 - 16:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This Biosimilar Medicinal Products Working Party (BMWP) workshop takes place as part of the consultation process following the Committee for Medicinal Products for Human Use (CHMP)'s adoption of the draft reflection paper on a tailored clinical approach in biosimilar development.

The event supports the implementation of the BMWP’s workplan and aligns with broader efforts to facilitate proportionate, science-based regulatory pathways for biosimilars. It takes place during the public consultation period, which runs until 30 September 2025.

The workshop brings together EU and non-EU regulators, international partners, patient and healthcare professional organisations, academia, and industry stakeholders to discuss the proposed approach and provide feedback on the draft document.

Objectives of the workshop:

• gather targeted feedback from stakeholders on the draft reflection paper;
• promote awareness and understanding of the proposed tailored approach to biosimilar development;
• support the finalisation of the reflection paper by considering practical insights and scientific perspectives.

Key messages:

• the draft reflection paper outlines a proportionate approach to biosimilar development;
• in certain cases, robust analytical and pharmacokinetic data may replace the need for extensive confirmatory clinical trials;
• the aim is to accelerate patient access to biosimilars without compromising quality, safety or efficacy;
• stakeholder input is essential to ensure the final reflection paper is scientifically sound, fit for purpose, and internationally relevant.

Registration

• Registration is open unil 15 September 2025
  Note that in-person attendance is by invitation only

Documents

Agenda - Multi-stakeholder workshop on tailored clinical approach for biosimilars