Europe – Europe closer to biosimilar rule change, despite fierce resistance from pharma

EFPIA says its weakens IP commitment - supporters say it will boost exports. The European Union is a step closer to introducing new rules aimed at boosting exports of generics and biosimilars from the region – despite dogged opposition from the pharmaceutical industry.

Europe’s pharma industry body EFPIA says the changes send a signal that Europe is “weakening its commitment to IP incentives and innovation”. However the generics and biosimilar sector says this is scaremongering, and the move will in fact boost its exports and create jobs, without doing any harm to innovation-based pharma.

European leaders are close to finalising the regulation change, which will see a new ‘manufacturing waiver’ to the supplementary protection certificate (SPC), an existing law which extends market exclusivity for branded medicines inside the EU.

The waiver is being introduced because generic and biosimilar companies in Europe have been blocked by strict rules which prevent them from manufacturing their copies before the SPC expires.

Ministers from EU member states have now backed the reform, with just the European Parliament needed to agree the changes, which could start to apply from 2021.

Europe’s generics and biosimilar firms, represented by trade association Medicines for Europe, says their competitors in Canada, India and China have no such restrictions, and can be ready to launch their versions on ‘Day 1’ of exclusivity ending – giving them a major competitive advantage…