- First Generic and clinically validated product for Multiple Sclerosis in Europe
- Provides an affordable high quality alternative to MS patients, complemented by a range of support services including AutoxonTM.
Alvogen today announced the launch of RemurelTM (glatiramer acetate), the first generic equivalent of CopaxoneTM in Central and Eastern Europe. The product will be marketed as a once daily subcutaneous 20 mg prefilled syringe under the brand name RemurelTM and will be launched throughout all Central and Eastern European countries from September 2016 onwards.
The product will be launched with a proprietary auto-injector device (AutoxonTM) having multiple features to help support MS patients in their treatment with RemurelTM. Teva‘s CopaxoneTM delivered sales of over EUR 510 million in Europe in 2015, according to IMS Midas data.
Hacho Hatchikian, Executive Vice President at Alvogen in the CEE region, commented:
RemurelTM is indicated for the treatment of patients with relapsing-forms of multiple sclerosis (RRMS), a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. RemurelTM 20 mg was determined by the European health authorities to be therapeutically equivalent to daily CopaxoneTM 20 mg, with the same active ingredients, route of administration, strength and dosage form. This approval was supported by a large-scale, multicenter Phase III study, known as GATE (Glatiramer Acetate clinical Trial to assess Equivalence to Copaxone®). Results of the study demonstrate equivalence in efficacy and safety and support the safety of switching active therapy from CopaxoneTM to Remurel^TM^.