EMA Concept Paper: Revision of the Guideline on Similar Biological Medicinal Products

Sharan Murugan
2 hours ago
3 min read

Biosimilar medicines have become an integral part of modern healthcare by expanding patient access to biological therapies while maintaining high standards of quality, safety, and efficacy. As scientific knowledge, analytical technologies, and regulatory frameworks continue to evolve, regulatory guidance must also adapt to reflect these advancements. The Concept Paper on Revision of the Guideline on Similar Biological Medicinal Products sets out the European Medicines Agency's proposal to revise the existing overarching biosimilar guideline. The concept paper explains the scientific and regulatory factors driving the revision, identifies the major areas that require updating, and outlines the planned approach for developing a revised guideline that supports future biosimilar development and regulatory decision-making.

Problem Statement

The current guideline was last revised in 2015. Since then, considerable progress has been made in analytical sciences and the regulatory field of biosimilars. Two important developments have highlighted the need for an updated guideline.

The first is the publication of the Reflection Paper on a Tailored Clinical Approach in Biosimilar Development and the ongoing development of the ICH M18 Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs. The second is the New Pharmaceutical Legislation (NPL), which proposes changes to the legal and regulatory definition of a biosimilar.

These developments demonstrate the need to update the guideline so that it reflects current legal, regulatory, and scientific expectations.

Discussion

The Biosimilar Working Party (BMWP) recommends revising the guideline to address these developments. A primary objective of the revision is to provide updated high-level guidance on the necessity and utility of Comparative Efficacy Studies (CES), taking into account the scientific considerations presented in the Reflection Paper, the ongoing development of the ICH M18 guideline, and regulatory experience gained through Scientific Advice procedures and CHMP decisions on biosimilar marketing authorisation applications.

The revised guideline is also intended to reflect the updated legal definitions and associated high-level data requirements proposed under the New Pharmaceutical Legislation. In addition, other sections of the guideline may be reviewed, updated, or clarified based on regulatory experience.

Recommendations

The Working Party recommends proceeding with the revision of the guideline while addressing the identified scientific and regulatory developments. The revised guideline should incorporate the updated legal definitions and associated data requirements for biosimilars. Other sections of the guideline may also be amended or clarified where appropriate based on current regulatory experience.

Proposed Timeline

A three-month public consultation period has been proposed. Following consultation, the Biosimilar Working Party plans to publish a draft revised guideline for consultation in the second quarter of 2027, with adoption of the final guideline anticipated in 2028.

The concept paper notes that the primary risk to the proposed timeline is the need for detailed discussion and evaluation of the updated definitions introduced through the New Pharmaceutical Legislation.

Resource Requirements

The revision will be developed through the Biosimilar Working Party without establishing a separate drafting group. However, dedicated subgroups may be formed to address specific issues or sections of the guideline, while regular Working Party meetings will support the drafting process.

Anticipated Impact

The concept paper states that the scientific impact of the revision is not expected to be significant because the Reflection Paper has already been published and has been followed by several regulatory procedures. However, the revised guideline is expected to strengthen the regulatory basis for tailored biosimilar development by aligning with the Reflection Paper, supporting global harmonisation efforts, and incorporating regulatory experience from biosimilar marketing authorisation applications that did not include Comparative Efficacy Studies.

Interested Parties

Following publication of the concept paper, an interested parties meeting is planned to obtain external expert input on the guideline revision. The need for additional stakeholder meetings will be determined as the revision progresses.