19 Aprile


Generics and biosimilars: the European Parliament approves the new regulation that eliminates the obligation to wait for the SPC to expire


On April, 17th, the European Parliament approved the text of the new regulation on supplementary protection certificates; in amending Regulation (EC) 469/2009, it introduces the possibility for pharmaceutical companies established in the European Union to produce generics and biosimilars during the validity period of the supplementary protection certificate (SPC) of the originator product of reference in order to export them to a third country where the product patent has expired or never existed. It will also be possible to produce generics and biosimilars before the SPC of the originator product expires, in order to stock them in the EU and put them on the market immediately after the expiry of the certificate. The newly approved regulation also provides that certain information (such as manufacturer name and address, purpose of production, the Member State of production or storage) is communicated by the manufacturer of generics and/or biosimilars to the competent authority and to the holder of the SPC. These new provisions will apply from the date of entry into force of the regulation for new certificates requested from such date, and from 1 July 2022 will also apply to those previously requested and effective after the entry into force of the regulation itself.