1. Generics Bulletin

European Parliament Passes SPC Manufacturing Waiver

 
• By Dave Wallace

A waiver to allow manufacturing of generics and biosimilars during the term of supplementary protection certificates is on the verge of being realized after the European Parliament approved the Regulation by a large majority.

Brussels
The Parliament Passed The SPC Manufacturing Waiver By A Wide Majority • Source: Shutterstock

Europe’s off-patent industry has welcomed the European Parliament’s decision to approve by a significant majority a Regulation setting out a waiver that will allow firms to manufacture generics and biosimilars during the term of supplementary protection certificates (SPCs).

“The European Parliament today voted overwhelmingly with 572 members of parliament in favour to adopt the SPC manufacturing waiver,” celebrated European off-patent industry association Medicines for Europe, insisting that the waiver would “improve

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