The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have emphasised that biosimilars approved in the EU are interchangeable from a scientific viewpoint, meaning that a biosimilar can be used instead of its reference product, or vice versa. A biosimilar can likewise be used in place of another biosimilar of the same reference product.

The Federal Institute for Drugs and Medical Devices (BfArM) supports this scientific position.

EU Member States continue to decide which biological medicines are available for prescribing in their country and whether automatic substitution with biosimilars is allowed at pharmacy level.

In Germany, the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA) addresses the interchangeability of "essentially identical biotechnologically produced biological medicinal products within the meaning of Article 10(4) of Directive 2001/83/EC (biosimilars)" at the pharmacy level, see:

• Rules of Procedure: Addition of a title in Chapter 4 - Exchange of Biosimilars (in German language)
• Medicinal Products Directive Annex VIIa: Biologics and Biosimilars (in German language).

The EMA/HMA statement aims to address any uncertainty among prescribers of biological medicines and to support patient access to biosimilars for treating diseases such as cancer, diabetes and rheumatic diseases.

Further details on the EMA/HMA statement are available on the EMA website under:

• Interchangeability of biosimilar medicines in the EU
• EMA press release (19.09.2022) on the interchangeability of biosimilars