The EU recently adopted new measures to increase the competitive strength of its generic and biosimilar manufacturers. Regulation (EC) No 469/2009.
This new legislation will grant exceptions to the protection of original medicines (SPC - Supplementary protection certificate) in the case of export or stockpiling for EU 'day-one' entry.
Due to this new rule, EU manufacturers will be allowed to produce generic medicines or a biosimilar versions of a SPC protected medicine while the SPC is still in force, if the purpose of this manufacturing is for export to a non EU country where protection has already expired or never existed previously.
In the case of EU stockpiling, the new measure grants producers the right to start manufacturing during the six month period before SPC expiration.
This new measure will ensure rapid entry into market of generics and biosimilars on expiration day.
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