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.
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Roche plans to appeal against a penalty imposed by the Romanian competition authorities for implementing strategies that were said to delay the entry of competing biosimilar and generic products.
The EU association representing parallel traders says cheaper parallel imports are vital in keeping medicines affordable for member states.
The latest drug safety actions by the European Medicines Agency affect products for dermatological use and vaginal atrophy.