The European Medicines Agency (EMA) has opened a public consultation on a concept paper proposing a revision of the Guideline on similar biological medicinal products (CHMP/437/04 Rev.1), aiming to update the regulatory framework for biosimilars in light of scientific progress and the forthcoming New Pharmaceutical Legislation (NPL). The consultation, launched on 22 July 2026, runs until 31 October 2026.
The concept paper, agreed by the Biosimilar Working Party (BMWP) in June 2026 and adopted by the Committee for Medicinal Products for Human Use (CHMP) on 13 July 2026, identifies two key drivers for the revision. First, major advances in analytical sciences and regulatory experience, including the EMA's Reflection paper on a tailored clinical approach in biosimilar development and the ongoing ICH M18 guideline on the utility of comparative efficacy studies (CES). Second, the NPL, which will amend the legal definition of a biosimilar and introduce new data requirements.
The revision aims to provide updated high-level guidance on the necessity and utility of CES, incorporating scientific considerations from the reflection paper, the ICH M18 work, and recent regulatory experience from scientific advice procedures and CHMP decisions on biosimilar marketing authorisation applications. The guideline will also be aligned with the new legal definitions and data requirements under the NPL, and other parts may be reviewed or clarified based on accumulated experience.
Stakeholders are expected to be impacted differently. Biosimilar developers may benefit from clearer guidance on when comparative efficacy studies are needed, potentially reducing development costs and time. However, the revision could also impose new data requirements aligned with the NPL, increasing the regulatory burden for some applicants. National competent authorities and EMA committees will need to adapt to updated scientific standards, while patients may gain faster access to more affordable biosimilars if the guidance streamlines approval pathways. The revision is expected to be finalised after the consultation period, with the new guideline replacing the 2015 version.