Reflection paper on a tailored clinical approach in biosimilar development

The European Medicines Agency (EMA) is exploring an improved approach for biosimilar medicine development and evaluation, while upholding strict European Union (EU) safety standards. This is outlined in a reflection paper on biosimilar development. Its aim is to utilise experience and technical advances to optimise biosimilar development and reduce the amount of clinical data required for the development and approval of biosimilar medicines in the EU.

A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (Reference Medicinal Product, RMP), where similarity to the reference medicinal product based on a comprehensive comparability exercise has been established. Biosimilars have become important therapeutic options, improving patient access to essential treatments. Therefore, CHMP (EMA) acknowledges the significance of biosimilars.

Previously, the required comparability exercise comprised quality data (analytical comparability exercise), in vitro non-clinical data, and comparative clinical studies (e.g. pharmacokinetic, pharmacodynamic, safety and efficacy). However, considering the advances in the analytical sciences and the extensive regulatory experience gained, the importance of dedicated comparative clinical efficacy and safety data are re-evaluated. As a result, Comparative Efficacy Studies (CES) may not be required for well characterised biological substances where the analytical comparability exercise provides a more sensitive determination of biosimilarity, in conjunction with PK and appropriate safety studies. 

Keywords:  reflection paper, biosimilar, comparative efficacy study, tailored clinical approach

Current version

Reflection paper on a tailored clinical approach in biosimilar development

Adopted Reference Number: EMA/CHMP/BMWP/60916/2025

Document history

Reflection paper on a tailored clinical approach in biosimilar development

Draft: consultation closed Consultation dates: 01/04/2025 to 30/09/2025 Reference Number: EMA/CHMP/BMWP/60916/2025 Summary:

This is a draft reflection paper on a tailored clinical approach in biosimilar development and evaluation is available for public consultation.

This approach could reduce the amount of clinical data required to develop and approve biosimilar medicines.

Stakeholders can comment on the reflection paper until 30 September 2025 via the EU survey below:

• EU survey: Submission of comments on the draft "Reflection paper on a tailored clinical approach in biosimilar development"

Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development

Draft: consultation closed Consultation dates: 01/02/2024 to 30/04/2024 Reference Number: EMA/CHMP/BMWP/35061/2024