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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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A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.

Coronavirus Notebook: MHRA Begins Rolling Review Of Moderna Vaccine, Sanofi/GSK Hook Up To COVAX

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UK Confirms It Will Accept EU Marketing Authorizations For Two Years

New guidance from the UK covers the recognition of EU approvals, accelerated assessment, rolling reviews, and much else besides.

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