1st Generic for Copaxone to Treat Relapsing MS Available in Central and Eastern Europe

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by Patricia Silva, PhD |

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MS generic approved in Europe

Alvogen recently announced the launch of Remurel (glatiramer acetate) in Central and Eastern Europe, making it the first generic equivalent of Copaxone  to be clinically validated for the treatment of relapsing forms of multiple sclerosis (RRMS) in Europe.

European health authorities determined that Remurel 20 mg was the therapeutic equivalent to daily Copaxone 20 mg (glatiramer acetate, Teva Pharmaceuticals), with the same active ingredients, route of administration, strength, and dosage form. The approval is supported by results from a large-scale, multicenter Phase 3 clinical trial (GATE) (NCT01489254).

The GATE (Glatiramer Acetate clinical Trial to assess Equivalence to Copaxone) study demonstrated the efficacy and safety of Remurel in comparison to Copaxone, and in that of switching from the older therapy to Remurel.

“We are proud to announce the launch of Remurel. This product represents an important milestone in our growing portfolio in the region. It is also a landmark for Alvogen and MS patients throughout the CEE region, who will finally have access to an affordable high quality treatment for this chronic and neurodegenerative disease,” Hacho Hatchikian, Alvogen’s executive vice president in the CEE region, said in a press release.

Remurel will be marketed as a once-daily subcutaneous 20 mg prefilled syringe with a proprietary auto-injector device, called Autoxon, to make its use easier for patients, the company said in the release.

In the clinical trials for Copaxone, the most common adverse reactions reported were skin problems at the injection site, flushing or vasodilation, rash, shortness of breath, and chest pain.

The U.S. Food and Drug Administration approved Glatopa, manufactured by Sandoz, a Novartis company, as a generic and equivalent injectable form of Copaxone in April 2015.

Glatiramer acetate is a synthetic protein that mimics the myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. It appears to work by blocking myelin-damaging T-cells, although the mechanism by which it does so is not completely understood, according to the National Multiple Sclerosis Society.

RRMS is the most common form of multiple sclerosis, a chronic disease affecting the central nervous system (CNS) and one characterized by recurrent inflammation and neurodegeneration.

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