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”.