The European Medicines Agency and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilars approved in the European Union are interchangeable with reference medicines or equivalent biosimilars.
EMA: Biosimilars can be used interchangeably
Published Sept. 20, 2022 11:06
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The use of biosimilar medicines is already practiced in many Member States, incl. in Poland. The position thus unifies the approach of the European Union in this matter. As a result, more patients will be able to access biological therapies.
- This is good news for patients and healthcare professionals who have greater access to important treatment options for treating serious diseases such as cancer, diabetes and rheumatoid arthritis. EMA has approved 86 biosimilars since 2006. These drugs have been carefully analyzed and monitored over the past 15 years and experience in clinical practice has shown that they are comparable to their reference products in terms of efficacy, safety and immunogenicity and are therefore interchangeable, says Emer Cooke, executive director of EMA./p>
Biosimilar drugs are biological drugs that are highly similar to another, already marketed, biological drug. If the active substance is a protein, the biosimilar medicine and the reference medicine must contain the same protein, in the same 3D structure. The preparations have to be dosed in the same way and administered by the same route.
