European SPC Waiver Becomes A Reality With Council Adoption

Less than a month after it was passed by the European Parliament, a waiver to allow manufacturing of generics and biosimilars during the SPC period, as well as stockpiling for a European ‘day one’ launch upon SPC expiry, has been formally adopted by the European Council.

FinishLine
The long-awaited SPC waiver has passed the finishing line • Source: Shutterstock

A final milestone has been passed by the European Regulation for a waiver that will allow firms to manufacture generics and biosimilars during the term of supplementary protection certificates (SPCs), after it was formally adopted by the European Council.

The Council’s move comes just under a month after Europe’s off-patent industry celebrated the European Parliament’s decision to approve the...

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