Viatris launches low-dose Copaxone generic formulation in Canada

Viatris has launched a generic version of low-dose Copaxone (glatiramer acetate) in the Canadian market for the treatment of people with relapsing-remitting multiple sclerosis (RRMS) who retain the ability to walk.

Called Glatiramer Acetate Injection 20 mg/mL, the product was approved in Canada as a generic of Copaxone in September 2023. It’s given as a once-daily subcutaneous or under-the-skin injection, and is designed to prevent multiple sclerosis (MS) relapses and reduce the number and volume of active brain lesions on MRI scans.

Initially developed by Mylan, now part of Viatris, the newly launched product is the first generic bioequivalent of the 20 mg/ml dose of Copaxone. Glatect is another MS therapy that also contains the 20 mg/ml dose of glatiramer acetate, but it is not considered a generic in Canada.

“The launch of Glatiramer Acetate Injection 20 mg/mL, the first bioequivalent generic for Copaxone 20 mg/mL, marks another significant milestone for Viatris Canada, reinforcing our proven capabilities in bringing complex and difficult-to-manufacture products to market, and furthering our commitment to providing access to high quality medicines,” Jeffrey Long, Viatris Canada’s country manager, said in a company press release.

Long noted that Canada has “one of the highest rates of MS in the world,” with the release stating that this launch gives people in the country with the progressive disease a “new generic multiple sclerosis treatment option.”

Recommended Reading

December 22, 2023 News by Mary Chapman

Generics of Tecfidera not available in Europe until at least 2025

Product is 1st bioequivalent generic for Copaxone 20 mg/mL in Canada

It’s estimated that as many as 90,000 Canadians have MS, a disease in which the immune system mistakenly attacks the myelin sheath, a protective coating that wraps around nerve fibers, causing inflammation and damage in the brain and spinal cord.

“Because of this high prevalence, and because MS affects each person differently, there is a need for a range of medicines to help manage the symptoms of the disease and other medical conditions that are commonly associated with MS,” Long said.

Glatiramer acetate is a small man-made protein that is designed to mimic a piece of myelin. It contains four amino acids — the building blocks of proteins — found in myelin basic protein, a main component of myelin. The mechanism through which glatiramer acetate works in MS is poorly understood, but it’s thought that it modifies immune cell activity to lessen MS inflammation.

Because of [the] high prevalence [of multiple sclerosis in Canada], and because MS affects each person differently, there is a need for a range of medicines to help manage the symptoms of the disease and other medical conditions that are commonly associated with MS.

Viatris’ generic version, supplied in single-use pre-filled syringes, has been tested in preclinical studies with lab animals to ensure it matches the branded counterpart in terms of how it’s formulated, how it’s given, and its strength, according to the company.

As generics are usually sold at lower costs than the original medications, the launch of this medication is expected to make glatiramer acetate more easily available to patients.

The company launched a patient support program, called Viatris Advocate, to provide support with insurance, financial aid, training on how to self-inject, and ongoing guidance from nurses experienced in MS care. A similar program also is running in the U.S.