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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A total of 13 new drugs have been recommended for pan-EU approval, while one has failed to meet the European Medicines Agency’s standards.
The Russian backers of the vaccine’s development say that if it receives a marketing authorization in the EU, distribution could begin in June this year.
Coronavirus Notebook: EU Moots Emergency Use Authorization Scheme For Vaccines, Janssen Product Up For 11 March Approval
Celltrion’s regdanvimab is undergoing an emergency use procedure in Europe, the European Medicines Agency and the health authorities in Canada have jointly published clinical data on the Moderna vaccine, and Canada has approved two versions of the AstraZeneca/Oxford University jab.