At its March 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted the EMA’s April 2025 “Reflection paper on a tailored clinical approach in biosimilar development”. Stakeholders had been invited to provide comments on the draft reflection paper by 30 September 2025. The version of the paper adopted by the CHMP can be accessed here.
As reported in April 2025, the reflection paper considers that waiving certain clinical data requirements would simplify the development and evaluation process of biosimilars while maintaining the highest standards of safety and efficacy.
According to the EMA, advances in analytical characterisation, and its extensive regulatory experience in approving significant changes in manufacturing processes of biological medicines by confirmation of structural and functional comparability, “supports the notion that under specific prerequisites, analytical comparability exercises and pharmacokinetic (PK) data can be sufficient for demonstrating biosimilarity”.
The reflection paper concludes that a tailored approach for clinical development of biosimilar candidates is possible, with Comparative Efficacy Studies no longer expected to be required for approval of biosimilars that can be “thoroughly characterised using state-of-the-art analytical methods and [which] have demonstrated similarity in physicochemical and functional properties”. The paper expects this tailored clinical approach to be “applicable for the majority of biosimilar candidates”.