ICH Moves Toward Harmonised Biosimilar Development Guidelines

During its Assembly Meeting on 18–19 November, the International Council for Harmonisation (ICH) Management Committee approved several final documents and endorsed a new concept paper on the use of real-world evidence in regulatory decision-making. The committee also published guideline M18, which focuses on evaluating the need for comparative efficacy studies (CES) in biosimilar development.

The planned multidisciplinary guideline aims to establish clear, global criteria for determining when CES are necessary and when they can be waived without affecting assessments of efficacy, safety or immunogenicity. Although CES were traditionally required, advances in analytical and quality testing now allow more sensitive detection of differences between biosimilars and reference products, often reducing the added value of clinical efficacy studies.

M18 introduces a risk-based framework to harmonise regulatory expectations worldwide, improve development efficiency and avoid unnecessary studies. An expert working group will prepare a draft within 18 months, with final completion expected within three years.

17-12-2025