EU Adopts Regulation in Support of EU-Based Generics and Biosimilars Producers

Regulation (EU) 2019/933 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products was published in the Official Journal of the EU on June 11, 2019 and entered into force on July 1, 2019.

Regulation (EU) 2019/933, which was recently submitted to the European Parliament and the Council for formal adoption, introduces an exception allowing EU-based manufacturers of original generics and biosimilars to manufacture a generic or biosimilar version of an SPC-protected drug during the supplementary protection certificate (SPC) term, for export and/or stockpiling purposes. This is expected to remove the competitive disadvantages EU-based generics and biosimilars manufacturers are currently facing when competing beyond home markets with manufacturers based outside the EU.

Prepared by: Maja Žnidarič

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Source: EUR-Lex platform