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EU Reforms Offer Mixed Blessings For Generics And Biosimilars

Changes To Regulatory Data Protection And Faster, Simpler Authorization Procedures

Executive Summary

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.

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Reacting to the latest position on the EU pharma legislation overhaul adopted by a European Parliament committee – including changes to previous proposals on regulatory data protection – Medicines for Europe said that the “imperfect” compromise nevertheless offers improvements.

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Pricing and reimbursement processes as well as health technology assessments should be explicitly included in the procedures that can be conducted for generic and biosimilar products without infringing patent rights, according to the European Commission’s legislative revision proposals.

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