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EU Biosimilar Filings, Opinions And Approvals

 
• By Ian Schofield

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Opinions Approvals
• Source: Shutterstock

The table below shows EU regulatory developments in the biosimilars area in 2018-24. It covers new product filings with the European Medicines Agency, opinions from the EMA’s drug evaluation committee, the CHMP, withdrawals of marketing authorization applications (MAAs), and decisions on biosimilar marketing authorizations by the European Commission.

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