In September 2025, the European Medicines Agency’s (EMA) Biosimilar Medicinal Products Working Party (BMWP) held a ‘Workshop on a tailored clinical approach in biosimilar development’ to discuss with its stakeholders the proposed tailored clinical approach in biosimilar development.
The BMWP is a multi-disciplinary group that brings together expertise in quality and clinical assessment of biosimilar medicinal product applications. It provides recommendations to the Committee for Medicinal Products for Human Use (CHMP) on quality and clinical matters relating to biosimilar medicines [1]. The BMWP held the workshop on 22 September 2025 as part of the consultation process of the ‘Draft Reflection paper on a tailored clinical approach in biosimilar development’ [2].
In attendance were EU and non-EU regulators, international partners, patient and healthcare professional organisations, academia, and industry stakeholders, the EU drafting group of the draft Reflection Paper. Additionally, chairs and members of the BMWP, Biologics Working Party (BWP), the Scientific Advice Working Party (SAWP), Methodology Working Party (MWP), and the CHMP were also present. The workshop was a hybrid meeting with over 800 registrants.
One of the key discussion points at the workshop was the support for a science-driven tailored approach as the next step in the evolution of the biosimilar regulatory pathway. This evolution is driven by accumulated regulatory experience and advances in analytical methods, which can reduce, but not universally eliminate, the need for comparative efficacy studies (CES). CES have been shown to be less sensitive in detecting product differences than analytical and pharmacokinetic (PK) methods.
The consensus was that for well-characterized molecules, a robust analytical and comparative PK dataset can often serve as the primary foundation for demonstrating biosimilarity. Maintaining high scientific standards is paramount, and CES should be reserved for specific cases where critical scientific questions cannot be answered by other means, e.g., poorly characterized molecules, non-meaningful clinical PK.
Furthermore, the workshop emphasized several critical supporting elements:
- Statistical Approaches: The impact of statistical methods on biosimilar assessments was highlighted as an area requiring further discussion, with case studies presented to illustrate their importance.
- Reference Product (RP) Flexibility: The regulatory framework for the RP must provide flexibility to accommodate ongoing scientific advances and the unique aspects of evolving product classes.
- Harmonisation: The importance of harmonizing requirements for international convergence and global acceptance was agreed upon.
- Transparency: Providing a public rationale for a tailored development approach is essential for building trust and knowledge among all stakeholders.
- Pre-approval Evidence: It was reinforced that while pharmacovigilance is crucial for ongoing safety monitoring, the full evidence for biosimilarity must be established prior to approval.
Overall, it was noted that tailored development described in the draft Reflection Paper [2] supports a more efficient regulatory pathway, consequently enabling development and delivery of biosimilar/biological medicines to patients. The final revision of the Reflection Paper, which will have input from the discussions of this workshop, is expected in mid-2026.
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References
1. https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups
2. 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 Nov 21]. Available from: www.gabionline.net/policies-legislation/ema-concept-paper-towards-a-tailored-clinical-approach-in-biosimilar-development
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