Swissmedic aligns biosimilar guidance with EMA’s tailored clinical approach

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Swissmedic aligns biosimilar guidance with EMA’s tailored clinical approach

INICIO/Directrices | Posted 03/11/2026 0 Post your comment

Swissmedic has revised its Guidance document Authorisation Biosimilar to align with the European Medicines Agency’s (EMA) finalised reflection paper on a tailored clinical approach in biosimilar development, effective 1 October 2026.

The updated guidance eliminates the blanket requirement for Comparative Efficacy Studies (CES) for well-characterised biological active substances. Under the new framework, CES are no longer mandatory if a comprehensive analytical comparability assessment, combined with pharmacokinetic and appropriate safety data, can demonstrate sufficient biosimilarity with higher sensitivity. Swissmedic attributed this policy shift to significant advances in analytical sciences and the extensive regulatory experience accumulated to date.

The EMA’s reflection paper, adopted on 16 March 2026, established that CES have typically not added pivotal information for assessing biosimilarity [1]. The prerequisites for waiving CES include comprehensive knowledge of the molecule’s mechanism of action, detailed characterisation of critical quality attributes using state-of-the-art orthogonal methods, and a validated manufacturing process ensuring batch-to-batch consistency.

Swissmedic additionally updated its process for extrapolating indications from the reference product to the biosimilar. A further practical change requires the ‘Date of revision of the text’ in biosimilar product information to match that of the reference product, which marketing authorisation holders can implement during their next variation application.

While Swissmedic aligned with the EMA, the US Food and Drug Administration (FDA) advanced a parallel but distinct reform. On 29 October 2025, the FDA issued a draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, which proposed that a CES may be unnecessary when analytical and pharmacokinetic data leave no residual uncertainty about clinically meaningful differences [2]. FDA officials cited the ‘relatively low’ sensitivity of comparative efficacy studies compared with analytical comparisons as the scientific rationale.

Canada has moved in the same direction. Health Canada's updated Guidance on Information and Submission Requirements for Biosimilar Biologic Drugs, published on 19 May 2026, states that clinical CES ‘are not typically required’ and that similarity should be deduced primarily from comprehensive analytical studies [3].

The convergence of EMA, Swissmedic and FDA positions signals growing regulatory acceptance that, for well-characterised biologics, analytical and functional characterisation rather than confirmatory efficacy trials can serve as the most sensitive tool for establishing biosimilarity.

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA adopts landmark reflection paper on tailored clinical approach for biosimilars [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Nov 3]. Available from: www.gabionline.net/guidelines/ema-adopts-landmark-reflection-paper-on-tailored-clinical-approach-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. US guidance to remove biosimilar comparative efficacy studies [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Nov 3]. Available from: www.gabionline.net/guidelines/us-guidance-to-remove-biosimilar-comparative-efficacy-studies
3. GaBI Online - Generics and Biosimilars Initiative. Canada eliminates phase III trial requirement for biosimilar approvals [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Nov 3]. Available from: www.gabionline.net/guidelines/canada-eliminates-phase-iii-trial-requirement-for-biosimilar-approvals

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