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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Regulators have pulled out all the stops in their efforts to get the Ebola vaccine to the marketing authorization stage in Africa.
At the end of the Brexit transition period, the UK will be charting its own course through the often choppy seas of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced therapies and product labeling.
Life science companies will be pleased to hear that the European Parliament is pressing for close cooperation between the UK and the EU in the area of medicines regulation.