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Alvogen obtains first approval for glatiramer acetate 40 mg/mL in Europe

05 October 2017
  • First three times weekly glatiramer 40 mg/mL
  • Approval obtained, in close collaboration with partner Synthon
  • Provides an affordable, high-quality alternative to MS patients, complemented by a range of support services including AutoxonTM

Alvogen today announced the successful closure of the decentralized procedure for RemurelTM (glatiramer acetate) 40 mg/mL, the first generic equivalent of CopaxoneTM 40 mg/mL in Europe.

Alvogen is already successfully marketing a once daily subcutaneous 20 mg/mL prefilled syringe under the brand name RemurelTM. The approval of the generic three times weekly 40 mg/mL is excellent news for the multiple sclerosis community, providing a high-quality and affordable alternative.

Teva‘s CopaxoneTM delivered sales of over EUR 505 million in Europe in 2016, according to IMS Midas data.

The successful DCP closure and approval of Alvogen's glatiramer acetate 40 mg/mL, therapeutically equivalent to Copaxone® 40 mg/mL, marks another significant milestone for our company, reinforcing our proven capabilities in bringing complex and difficult-to-manufacture products to market ahead of the competition, and further underlining our commitment to providing access to high-quality and affordable medicines.

Hacho Hatchikian

Executive Vice President at Alvogen in the CEE region