EU Proposal To Address Impact Of Duplicate Marketing Authorizations On Biosimilars Availability
Executive SummaryThe European Commission has proposed updating its guidance on duplicate marketing authorizations to address concerns regarding the availability of biosimilars.
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The European Commission has issued a revised note on how it handles requests from pharmaceutical companies for duplicate marketing authorisations1,2. The revised note, among other things, attempts to clarify a misunderstanding by applicants of the term "true duplicate" in the March 2010 version of the document3,4.
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