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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 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

Having finally unveiled a long-awaited set of proposals to overhaul the EU’s pharmaceutical legislation, the European Commission has highlighted 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...

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Spain’s Medicines Shortages Plan Clears Administrative Hurdles For Essential Medicine Manufacturers

 
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