1. Generics Bulletin

EMA And HMA Speak Out In Favor Of Biosimilar Interchangeability

All Biosimilars Can Be Substituted In EU With Member States’ Consent

 
• By Chloe Kent

Stakeholders in Europe have been hesitant to allow interchangeable substitution of biological products, prompting the European Medicines Agency to clarify its stance on the issue.

Pharmacist speaking to patient at counter
Biosimilar interchangeability has a notably different meaning in the US compared to the EU • Source: Shutterstock

The European Medicines Agency and Heads of Medicines’ Agencies Biosimilars Working Group has issued a statement highlighting its support for biosimilar interchangeability. The agencies have emphasized that biosimilars the EMA has approved are all interchangeable as a clinical matter and can be substituted for branded biologics wherever national regulatory agencies allow it.

Joint EMA/HMA Statement On Interchangeability
  • Interchangeability refers to the possibility of exchanging one medicine for another medicine that is expected to have the same clinical effect.
  • HMA and EMA consider that once a biosimilar is approved in the EU it is interchangeable, which means the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product

“Considering all the available scientific evidence and the successful experience with biosimilars in clinical practice over the years, the Committee for Medicinal Products for Human Use and all working parties with expertise in biological medicines and biosimilars support that

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