European approval for Alvogen and Synthon's glatiramer acetate 40mg/mL

5 October 2017

Coming hot on the heels of US Food and Drug administration approval of a generic version of top-selling multiple sclerosis treatment Copaxone (glatiramer acetate) 40mg/ml, two companies have been granted approval for the copycat versions of the Teva Pharmaceutical Industries (NYSE: TEVA) drug in Europe.

Privately-held US firm Alvogen today announced the successful closure of the decentralized procedure for Remurel (glatiramer acetate) 40mg/mL, claiming this to be the first generic equivalent of Copaxone 40mg/mL in Europe.

Alvogen is already successfully marketing a once daily subcutaneous 20mg/mL prefilled syringe under the brand name Remurel. The approval of the generic three times weekly 40mg/mL is excellent news for the multiple sclerosis community, providing a high-quality and affordable alternative, the firm said, adding that Teva‘s Copaxone delivered sales of over 505 million euros ($593 million) in Europe in 2016, according to IMS Midas data.

Synthon adds to 2016 approval of 20mg dose

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