First Generic Version of Copaxone Approved by FDA to Treat Multiple Sclerosis

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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CopaxoneThe U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version ofĀ CopaxoneĀ (glatiramer acetate injection) for the treatment ofĀ relapsing forms of multiple sclerosis (MS). The administration has grantedĀ Sandoz marketing authorization forĀ glatiramer acetate in 20 mg/1 ml daily injections.

The agency responsible for evaluating theĀ 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.

ā€œHealth 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,ā€ explained theĀ director of the Center for Drug Evaluation and Research at FDA,Ā Janet Woodcock, MD. ā€œBefore approving this generic product, given its complexity, we reviewed additional information toĀ make sureĀ that the genericĀ product is as safe and effective as the brand name product.ā€

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During the evaluation of a product for approval, the FDA may requireĀ appropriate information to prove the efficacyĀ ofĀ complex active ingredients, as is the case of glatiramer acetate. The clinical results of the studies conducted demonstrated the most common adverse effects wereĀ skin problems at the injection siteĀ such asĀ redness, pain, swelling and itching, flushing and rash, shortness of breath, and chest pain.

TheĀ approval was in partĀ related to the unmet need for more effective treatment options for chronic, inflammatory and autoimmune conditions such as MS. The FDA is part ofĀ the U.S. Department of Health and Human Services and works to superviseĀ 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,Ā andĀ Teva Pharmaceutical Industries Ltd., the company behind Copaxone, has been challengingĀ the FDA’s decision ofĀ approving a generic version of the drug developed by Mylan, Inc.Ā Tevaā€™s petition has been turned down several times, but the FDA has indicated it isĀ willing to hold a hearing if and when the generic formulation has been approved.