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Agreement On SPC Manufacturing Waiver Reached, Benefitting EU Generic, Biosimilar Industry

The European Council reached a political agreement today on the SPC Manufacturing Waiver, which will allow the manufacture of generic and biosimilar medicines in the European Union for export and stockpiling during the period of extended patent protection provided for by the EU. This waiver will enable EU generic and biosimilar industries to benefit from sales outside the EU where patents have already expired, and to prepare to provide the EU market as soon as the extended period of patent protection ends.
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Author: David Branigan

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