The European Medicines Agency (EMA) has formally adopted a landmark reflection paper that is set to streamline the development and approval of biosimilar medicines, potentially reducing the need for extensive and costly clinical efficacy studies.
The ‘Reflection paper on a tailored clinical approach in biosimilar development’ was adopted on 16 March 2026 by the EMA's Committee for Medicinal Products for Human Use (CHMP). The effort to streamline biosimilar assessments began with a Concept Paper in November 2023 [1], followed by a draft reflection paper published on 1 April 2025 [2], which was open for stakeholder comments until 30 September 2025. In September 2025, the EMA's Biosimilar Medicinal Products Working Party held a workshop with stakeholders to discuss potential improvements to the development and evaluation of biosimilar medicines while maintaining the European Union's stringent safety standards [3].
The new framework represents a significant shift in regulatory thinking, leveraging over two decades of EMA experience with biosimilars and major advances in analytical science. The agency concluded that for biosimilar candidates that can be ‘thoroughly characterised using state-of-the-art analytical methods’, demonstrated structural and functional comparability—combined with pharmacokinetic (PK) data—may now be sufficient to establish similarity to a reference medicine .
Under the previous standard, developers were typically required to conduct comparative efficacy studies (CES) to confirm similar clinical performance. The new approach indicates that such studies will no longer be expected for the majority of biosimilar candidates, simplifying the development pathway while maintaining strict safety and efficacy standards .
‘This more streamlined approach would ultimately ensure wider availability of biosimilar medicines to patients in the EU’, the EMA stated when the draft was initially proposed.
Swissmedic, the Swiss regulatory authority, has already announced its support for the principles outlined in the EMA reflection paper and is now accepting applications that omit comparative efficacy data.
Similarly, Canada issued a revised guidance on 10 June 2025, removing the requirement for biosimilar manufacturers to prove safety and efficacy through phase III clinical trials [4].
Industry stakeholders view the adoption as a ‘definite step towards a streamlined regulatory pathway for biosimilars as standard’, potentially lowering development costs and encouraging greater competition in the biological medicines market . The final paper is expected to be published in the coming weeks.
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References
1. 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 2026 Apr 8]. Available from: www.gabionline.net/policies-legislation/ema-concept-paper-towards-a-tailored-clinical-approach-in-biosimilar-development
2. GaBI Online - Generics and Biosimilars Initiative. Advances in EMA plans to streamline biosimilar assessment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 8]. Available from: www.gabionline.net/guidelines/advances-in-ema-plans-to-streamline-biosimilar-assessment
3. GaBI Online - Generics and Biosimilars Initiative. EU steps closer to the ‘tailored approach’ for biosimilars development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 8]. Available from: www.gabionline.net/reports/eu-steps-closer-to-the-tailored-approach-for-biosimilars-development
4. GaBI Online - Generics and Biosimilars Initiative. Canada poised to remove requirement for Phase III trials for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 8]. Available from: www.gabionline.net/guidelines/canada-poised-to-remove-requirement-for-phase-iii-trials-for-biosimilars
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