Regulatory Affairs

Synthon gets regulatory approval for glatiramer acetate 40 mg/ml in Europe

Published 09 October 2017

Synthon has concluded the decentralized procedures for glatiramer acetate 40 mg/ml pre-filled syringe for the treatment of relapsing forms of multiple sclerosis and received regulatory approval in Europe.

Synthon’s three-times-a-week glatiramer acetate is a therapeutically equivalent version of the originator medicine Copaxone®* 40mg. 

Synthon received regulatory clearance in all 27 EU/EEA member states involved in the procedures. Granting of national marketing authorizations will follow in the near future. 

Synthon’s 20 mg/ml glatiramer acetate product has already received marketing authorizations in these European countries. As of the end of 2016, Synthon's partners have introduced glatiramer acetate 20 mg/ml in the majority of these countries.

 “We are very pleased with this approval,” commented Synthon’s chief executive officer Jacques Lemmens. “It allows us to make an affordable version of the 40 mg/ml dosage strength of glatiramer acetate available to MS patients in Europe.”

Synthon, with headquarters in Nijmegen, the Netherlands, is an international pharmaceutical company and a leader in the field of generic medicines.

Source: Company Press Release