Sandoz Receives FDA Approval for the First Generic Version of Teva’s Multiple Sclerosis Drug Copaxone

Today, the US Food and Drug Administration (FDA) approved the first generic version of Teva Pharmaceuticals’ top-selling multiple sclerosis drug Copaxone (glatiramer acetate injection).

The agency approved Sandoz’s Abbreviated New Drug Application (ANDA) for once daily Glatopa 20 mg/mL, a generic equivalent of daily Copaxone 20 mg. Glatopa is now the first substitutable generic approved for the treatment of patients with relapsing forms of multiple sclerosis (RRMS). Since the drug is considered substitutable, prescriptions for the brand-name drug can be automatically switched to the generic version.

For the past four quarters, Copaxone generated $4.2 billion in sales for Teva, accounting for about 21 percent of the company’s revenues.

Sandoz developed the drug in partnership with Momenta Pharmaceuticals. The news sent Momenta’s shares up more than 12 percent. Under the collaboration, Momenta is eligible to receive up to $140 million in milestone payments surrounding Glatopa, including a $10 million payment earned upon sole FDA approval of the ANDA, and another $10 million milestone payment upon first commercial sale.

Glatopa is the second complex generic product the companies collaborated on to receive FDA approval.

“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,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is safe and effective as the brand name product.”

The agency said that its scientists established a thorough approach for demonstrating active ingredient sameness that takes into consideration the complexity of the drug.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system (CNS) that disrupts communication between the brain and other parts of the body. It is one of the most common causes of neurological disability in young adults. The debilitating disease affecting roughly 500,000 individuals in the US alone.

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

Sources: Food and Drug Administration; Sandoz

Last updated: 4/16/15; 2:40pm EST



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