EMA approves biosimilar interchangeability in EU

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product.

Interchanging biosimilars is an acceptable practise already used by many Member States. However, the current lack of certainty whether interchangeability is acceptable EU-wide has prompted this decision. Thus, public recommendation by the EMA as a major body highlights fundamental, positive progression for future EU regulatory practises.

Biosimilar medicines are biological medicines equivalent to existing approved biological medicines (reference medicines). This interchangeability refers to the fact that a reference medicine can be substituted by a biosimilar, without risk, side effects or outcomes different to the original drug.

“Over the past 15 years and the experience from clinical practice has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference products and are therefore interchangeable,” commented EMA’s Executive Director, Emer Cooke. She added that a major benefit of this change is that it provides patients and the pharmaceutical sector with “wider access to important therapeutic options to treat serious diseases such as cancer, diabetes and rheumatoid arthritis.”

Clinically, it is common practice for doctors to rotate patients between different biologics. Yet, this latest move enables clinicians to better understand what type of medicine they can offer to patients. Fundamentally, it modernises the accessibility of biological medicines for service users throughout the EU, so an EU-approved biosimilar can be used instead of its reference product (or vice versa). A biosimilar can also be replaced by a drug of the same reference product.

EU Member States individually manage decisions regarding the practice of supplying one medicine over another without checking with the prescriber. Analytical evidence by the EMA indicated that there was a lack of safety concerns regarding approval of biosimilars compared with their reference medicines. This was substantiated by safety data of over one million patient-treatment years. There has been no need for additional systematic switch studies for prescribers to perform.

EU experts from the Biosimilar Working Party and the Heads of Medicines Agencies Working Group of Biosimilars issued the statement. The Committee for Medicinal Products for Human Use (CHMP) endorsed the statement on 22 July 2022.