The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version of Copaxone (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (MS). The administration has granted Sandoz marketing authorization for glatiramer acetate in 20 mg/1 ml daily injections.
The agency responsible for evaluating the safety and security of medical and other products available in the country has evaluated data from the generic version of Copaxone produced by Sandoz to examine if it fulfilled the rigorous standards applied for the original product. The approval of Sandoz’s glatiramer acetate injections was based on the scientific approach used by the company to demonstrate the similarity of the active ingredient to the original Copaxone.
“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” explained the director of the Center for Drug Evaluation and Research at FDA, Janet Woodcock, MD. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.”
During the evaluation of a product for approval, the FDA may require appropriate information to prove the efficacy of complex active ingredients, as is the case of glatiramer acetate. The clinical results of the studies conducted demonstrated the most common adverse effects were skin problems at the injection site such as redness, pain, swelling and itching, flushing and rash, shortness of breath, and chest pain.
The approval was in part related to the unmet need for more effective treatment options for chronic, inflammatory and autoimmune conditions such as MS. The FDA is part of the U.S. Department of Health and Human Services and works to supervise the safety, effectiveness and security of drugs, vaccines, medical devices and other biological products to be commercialized in the United States.
There are a series of companies working to provide generic versions of Copaxone to U.S. patients, and Teva Pharmaceutical Industries Ltd., the company behind Copaxone, has been challenging the FDA’s decision of approving a generic version of the drug developed by Mylan, Inc. Teva’s petition has been turned down several times, but the FDA has indicated it is willing to hold a hearing if and when the generic formulation has been approved.