On 1 April 2025, the European Medicines Agency (EMA) published a ‘draft reflection paper on a tailored clinical approach in biosimilar development’ [1], which explores potential improvements to the development and evaluation of biosimilar medicines while maintaining the European Union’s (EU) stringent safety standards.
With over 20 years of experience in evaluating biosimilar medicines, the EMA hopes that refining evaluation procedures will enhance patient access to biosimilars across the EU. Additionally, the agency aims to ensure that Europe remains an attractive market for biosimilar development.
The EMA’s new proposed approach will potentially reduce the amount of clinical data required for the development and approval of biosimilar medicines.
The draft of the reflection paper was adopted by CHMP for release for consultation on 17 March 2025. The reflection paper concludes that ‘biosimilars may be approved without providing CES or even pharmacodynamic (PD) data if similar clinical efficacy and safety pharmacology can be inferred from a sufficiently stringent evaluation of analytical comparability, in vitro pharmacology, and a comparative clinical pharmacokinetic (PK) trial’. Stakeholders are invited to send their comments on the reflection paper via a survey until 30 September 2025.
Biosimilars are biological medicines that closely resemble an already approved reference (or originator) medicine. Their approval typically relies on a comparability exercise assessing the quality, safety, and clinical efficacy of the biosimilar against the reference product, including a thorough analysis of their active substances.
By the end of 2024, the EMA has approved 109 biosimilars in the product classes of: 1) human growth hormone; 2) granulocyte colony-stimulating factor; 3) erythropoiesis stimulating agent; 4) insulin; 5) follicle-stimulating hormone (FSH); 6) parathyroid hormone; 7) tumour necrosis factor (TNF)-inhibitor; 8) vascular endothelial growth factor (VEGF) inhibitor, and 9) monoclonal antibody for use in the EU [2].
Drawing on their many years of experience in regulating and approving biosimilars, and advancements in analytical technologies, the EMA draft reflection paper proposes that evidence of structural and functional similarity, along with pharmacokinetic data (how the drug behaves in the body), may be sufficient to establish biosimilarity. This approach could reduce the need for extensive clinical efficacy trials, streamlining the development and regulatory process without compromising safety or effectiveness.
This more streamlined approach would ultimately ensure wider availability of biosimilar medicines to patients in the EU.
The draft reflection paper builds on the 2024 concept paper on a tailored clinical approach in biosimilar development [3].
Related article
Comparative efficacy studies: where are we now?
References
1. Reflection paper on a tailored clinical approach in biosimilar development. https://www.ema.europa.eu/en/reflection-paper-tailored-clinical-approach-biosimilar-development
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
3. GaBI Online - Generics and Biosimilars Initiative. EMA concept paper towards a tailored clinical approach in biosimilar development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/policies-legislation/ema-concept-paper-towards-a-tailored-clinical-approach-in-biosimilar-development
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