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EC To Consult On Ways To Boost Generics & Biosimilars Industry, Introduce EU-wide SPC

 
• By Ian Schofield

A new package of measures from the European Commission will introduce an SPC export manufacturing waiver to help improve the competitiveness of Europe’s generics and biosimilars industry, while originator companies should benefit from steps to smooth out the rules on the “Bolar” research exemption and implement an EU-wide SPC.

Rules sign
Changes are on the cards for SPCs and Bolar in the EU

The European Commission is expected to launch a consultation soon on proposed changes to the rules on supplementary protection certificates aimed at increasing the competitiveness of the EU generic and biosimilar industry while ensuring that SPCs remain a strong incentive for originator companies to carry out R&D into new drugs.

The

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