EMA concept paper towards a tailored clinical approach in biosimilar development

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In November 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) published a 'Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development'. 

Concept Paper V13G05

This discusses the need to re-evaluate the current requirements for dedicated clinical efficacy and safety studies for biosimilars, with the aim to streamline the development and evaluation process while maintaining the highest standards of safety and efficacy.

It notes that biosimilarity of a biosimilar, as compared to a reference product, is based on a comprehensive comparability exercise comprised of Comparative Efficacy Studies (CES). The required comparability exercise comprises of quality data (analytical comparability exercise), in vitro and in vivo non-clinical data, and comparative pharmacokinetic (PK), pharmacodynamic (PD), safety and efficacy studies. However, the need for CES is increasingly questioned [1, 2] due to advances in analytical sciences and the extensive regulatory experience gained in biosimilars development.

CHMP highlights the need to keep the biosimilar pathway attractive for developers and simultaneously guarantee future access to safe and efficacious biologics for European patients.

As such, in the concept paper, CHMP notes it may be possible to further tailor the clinical approach for biosimilars and emphasizes the wealth of experience gained from previous marketing authorizations, particularly in quality comparability. They highlight that a reflection paper will be valuable to guide both developers and assessors of biosimilar medicinal products.

Further to this, the CHMP’s forthcoming reflection paper will evaluate whether or not an analytical comparability exercise, together with clinical PK/PD trials could allow for a conclusion of similarity, removing or tailoring the requirements for large Phase III studies in patients. 

The public consultation on this Concept Paper started on 1 February 2024 and will run until 30 April 2024.

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1. Easton RL. Front-loading biosimilar development with analytical characterization. Generics and Biosimilars Initiative Journal (GaBI Journal). 2022;11(2):82-4. doi:10.5639/gabij.2022.1102.013
2. GaBI Online - Generics and Biosimilars Initiative. WHO revised guidelines for biosimilars: scientific background [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 9]. Available from:

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