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

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

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