The drug – which will be sold as Remurel by Alvogen – is a three-times-a-week treatment for MS that has been deemed to be therapeutically equivalent to the originator product by the European Medicines Agency (EMA).
It was developed by Netherlands-based manufacturer Synthon.
CEO Jacques Lemmens said: “We are very pleased with this approval,” adding “It allows us to make an affordable version of the 40 mg/ml dosage strength of glatiramer acetate available to MS patients in Europe.”
A Synthon spokeswoman told us the firm will launch the product country-by-country, but declined to provide information on timelines.
Teva told us it “is aware that Synthon’s Decentralized Procedures for its 40mg/ml glatiramer acetate product has concluded positively on October 5, 2017 and the grant of National Marketing Authorizations will follow shortly.
“As with the 20 mg/ml glatiramer acetate product, Teva does not agree with the scientific and legal basis of Synthon’s marketing authorizations and will continue to challenge the regulatory approval of Synthon’s follow on glatiramer acetate products in Europe. “
The Israel-headquartered firm added that the 40mg, three-time-a-week version of Copaxone is “covered by a patent in Europe with a natural expiry date in 2030 as well as other intellectual property rights” adding it “will continue to defend the Copaxone franchise in Europe.”
The approval follows less than a month after the European Patent Office (EPO) revoked a key Teva patent EP 2 361 924 covering the synthesis process for the preparation of mixtures of trifluoroacetyl glatiramer acetate using purified hydrobromic acid.
It also comes days after Mylan NV launched 40mg and 20mg versions of glatiramer acetate in the US.