EU Biosimilar Filings, Opinions And Approvals

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.

The latest update of the table, compiled on 30 October, includes the approval of four biosimilar versions of ustekinumab (Janssen‘s Stelara) from Celltrion (SteQeyma), Samsung Bioepis

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