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New EU Approach On Duplicate Marketing Authorizations Prompts Questions

Executive Summary

The European Commission says there is no automatic link between the introduction of a duplicate marketing authorization by the holder of the original medicinal product (be it a chemical or a biological medicinal product) and the increased availability of a medicine. 

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EU considers duplicate biologics

A European Commission consultation on ‘duplicate marketing authorisations for biological medicinal products’ has been welcomed by off-patent industry association Medicines for Europe. According to the consultation – which is open until 10 September 2018 – the Commission has “identified potential issues relating to the granting of duplicate marketing authorisations for biological medicinal products on the ground that they would be a ‘first generic’”. These issues “relate to the possible impact of such duplicate marketing authorisations on the biosimilar market, including potential anti-competitive effects”.

EU explains criteria for issuing duplicate marketing authorisations

Pharmaceutical companies seeking duplicate/multiple marketing authorisations for drugs approved under the European centralised procedure can now refer to a new document issued by the European Commission that explains the criteria applied for granting such authorisations1,2.

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A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

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