Return to News. Food and Drug Administration has approved the first generic form of 40mg glatiramer acetate injection, produced by Mylan. This is the second approved generic for glatiramer acetate 20mg. These approvals mean that Mylan provided evidence that these generic medications are equivalent to the brand-name Copaxone.
There is no information yet about when these generics will become available for prescription, or what they might cost. Selecting a therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
More Details: The FDA has approved generic medications that have been shown to be equivalent to both the 40mg glatiramer acetate taken three times a week and the 20mg taken daily by subcutaneous under the skin injections. Glatiramer acetate is a synthetic protein that mimics myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord.
This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. This therapy has had a long track record of effectiveness and safety. As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations.
Clinical trials are generally not required to prove equivalence to a brand-name medication. The National MS Society will provide more information about these generic forms of glatiramer acetate as it becomes available. There is not information yet about when these medications may be available in the United States. Glatopa, a generic for daily glatiramer acetate, has been available since What will the generic glatiramer acetates from Mylan cost?
There is not information yet about the cost of these generics. Empowering Strategic Please login to the form below. I have forgotten my password. Advanced search. Generic Copaxone launches in US Sandoz and Momenta Pharmaceuticals started shipping Glatopa in reaction Teva's efforts to protect the US patents on its multiple sclerosis blockbuster Copaxone ended in failure yesterday when an appeals court cleared the way for generic versions of the drug.
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