FDA approves first generic Copaxone for MS treatment

The U.S. Food and Drug Administration last week approved the first generic version of Copaxone used to treat patients with relapsing forms of multiple sclerosis.

“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,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said. “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.”

The FDA granted Sandoz approval to market generic glatiramer acetate in a 20 mg/1 ml daily injection as Glatopa.

“Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy,” Peter Goldschmidt, president of Sandoz US, said. “The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products, and further demonstrates our commitment to offer patients and payers a full range of therapeutic options.”

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. For most MS patients, episodes of worsening function, called relapses, are primarily followed by recovery periods. Recovery periods may be shortened over time, leading to gradual decline in function.