Emer Cooke, director of the EMA.
The European Medicines Agency (EMA, for its acronym in English) has confirmed this Monday that the biosimilars approved in the community territory “are interchangeable” with the reference drugs or other equivalents. The organization led by Emer Cooke has highlighted the fact that 86 of these medicines have been approved over the last 15 years, offering patients and healthcare professionals new therapeutic options for diseases such as cancer, diabetes or rheumatoid arthritis .
The truth is that, from a scientific point of view, the interchangeability of biosimilar drugs “has always been considered acceptable and has not no worries”, emphasizes the EMA, which, however, until now had not established a clear position on the matter. “This has become a cause of uncertainty about the use of these drugs in clinical practice”; assumes the agency in a statement on the grounds that support the interchangeability of biosimilars.
In this regard, the European organization has ratified, together with the directors of the drug agencies (HMA), that drugs of this nature that have been approved within the framework of the European Union “are interchangeable with their reference drug or with an equivalent biosimilar.”
“Although the interchangeable use of biosimilars is already practiced in many Member States, this joint position harmonizes the EU approach and brings more clarity to health professionals”underlines the EMA, which recalls that biosimilars are drugs “very similar to other references already approved”, so that they do not produce “any change in the clinical effect”.
Biosimilars for serious diseases
According to EMA data, since 2006 Europe has approved 86 of these drugs, which during this time have been “exhaustively reviewed and controlled”. “Experience in clinical practice has shown that, in terms of efficacy, safety and immunogenicity, they are comparable to their reference products, and are therefore interchangeable,” reiterates Emer Cooke herself.
“This will allow more patients to have access to biological medicines necessary to treat diseases such as cancer, diabetes and rheumatic diseases”, stresses the director of the EMA, who highlights that it will be the Member States that continue to decide which drugs can be prescribed in each territory “and if the automatic substitution in pharmacies”.
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