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EU Biosimilar Filings, Opinions And Approvals

Executive Summary

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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EMA Doubles Number Of EU Early Access Approval Recommendations

The EU’s special provisions for speeding new products towards approval proved more popular than ever with drug sponsors last year.

Coronavirus Notebook: EMA Says ‘Wait And See’ On CureVac Data, EU Ministers Want Voluntary Approach To Sharing IP

AstraZeneca and the European Commission have both claimed victory in the Vaxzevria supply case brought against the company by the commission. The Moderna coronavirus vaccine is now under review by the European Medicines Agency for use in younger people.

Elzonris: A Case Study In Divergent Regulatory Decisions

Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.

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