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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The head of the European Medicines Agency says a group of international regulators got together to ensure “global alignment” on the approach to be taken on COVID-19 vaccination.
Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access
Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.
A new database being set up in Switzerland is expected to improve the exchange of GMP and GDP information between the regulatory authorities and pharmaceutical companies and offer free access to electronic certificates.