Biosimilar Medicinal Products Working Party

The Biosimilar Medicinal Products Working Party (BMWP) provides recommendations to the Committee for Medicinal Products for Human Use (CHMP) on clinical or non-clinical matters relating directly or indirectly to biosimilar medicines, and on the conduct of pharmaceutical tests on biosimilar medicinal products. These tests are needed to ensure the comparability of the old and new versions of biological medicinal products, when manufacturers make changes to such products during their lifecycle, or choose to develop new products which are biologically similar that could affect their quality, safety or efficacy.

The BMWP's work covers products that are already authorised through the centralised or mutual-recognition procedures, and those being developed. It works together with other CHMP working parties and scientific advisory groups, and co-operates with regulatory authorities in the Member States.

The tasks of the BMWP include:

• preparing, reviewing and updating guidelines to ensure that similarity and comparability issues are fully addressed;
• providing scientific advice to the CHMP and Scientific Advice Working Party on general and product-specific matters relating to the efficacy and safety of biosimilar medicinal products and to the comparability of biological and biotechnological medicinal products;
• contributing to international co-operation with other regulatory authorities;
• liaising with interested parties;
• contributing to comparability-related workshops and training.

Mandate, rules of procedure and work programme

Mandate, objectives, and rules of procedure for working parties under the quality, non-clinical, methodology, clinical and veterinary domains

Reference Number: EMA/299541/2025

3-year rolling work plan for the Biosimilar Medicinal Products Working Part) 2025-2027

Reference Number: EMA/276856/2024

Composition

The BMWP is composed of experts selected from the list of European experts maintained by the Agency. Up to eight experts, nominated by the CHMP according to their specific scientific expertise or regulatory experience constitute the BMWP's core group.

Additional experts from other CHMP working parties or scientific advisory groups may also be invited to participate in the work of the BMWP, as may observers from countries outside the European Economic Area.

Members

Below (in alphabetical order of surname) are the current members of the BMWP. The members' declarations of interests are available in the European expert list.

• René Anour (Chair)
• Niklas Ekman (Vice-Chair)
• Sarah Gilgunn
• Nils Jost
• Alexandre Moreau
• Sine Buhl Naess-Schmidt
• Pavel Simek
• Roeland Martijn Van der Plas
• Henrik Wahlstrom
• Martina Weise