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Europe Daily Bulletin No. 13024

20 September 2022
SECTORAL POLICIES / Health
European Medicines Agency and HMA express a common position on interchangeability of biosimilars approved in European Union
Brussels, 19/09/2022 (Agence Europe)

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that medicines which are highly similar to another reference medicine (known as biosimilars) that have been approved in the European Union are interchangeable with their reference medicine or with an equivalent biosimilar. 

Interchangeable” in this context means that the substitution of an approved reference drug with a biosimilar causes no change in clinical effect...

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SECTORAL POLICIES
INSTITUTIONAL
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Russian invasion of Ukraine
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