EU Reforms Offer Mixed Blessings For Generics And Biosimilars

Changes To Regulatory Data Protection And Faster, Simpler Authorization Procedures

A long-awaited package of European pharmaceutical legislation reforms unveiled by the European Commission contains a number of measures that will affect the generics and biosimilars industry – including changes to regulatory data protection periods, simplified marketing authorization procedures, and moves towards greater digitalization.

EU Flag On Capsule With Tablets
The European Commission has published its proposed pharma legislation reforms • Source: Shutterstock

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