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EU Reforms Offer Mixed Blessings For Generics And Biosimilars

Changes To Regulatory Data Protection And Faster, Simpler Authorization Procedures

 
• By Dave Wallace

A long-awaited package of European pharmaceutical legislation reforms unveiled by the European Commission contains a number of measures relating to generics and biosimilars – 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 proposed pharma legislation reforms • Source: Shutterstock

Having finally unveiled a long-awaited set of proposals to overhaul the EU’s pharmaceutical legislation, the European Commission has pointed to reforms that will help promote generic and biosimilar competition in Europe, including simplified marketing authorization procedures, measures that will allow for faster off-patent competition, and harmonization of the way the Bolar exemption functions across the EU.

As part of the proposals, the Commission has also suggested changes to regulatory data protection periods for originators that will both reduce the current standard eight-year period while also offering...

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