Novartis subsidiary Sandoz received approval from the Food and Drug Administration Thursday to market the drug Glatopa, the first generic alternative for Teva Pharmaceutical's multiple sclerosis treatment Copaxone.
Sandoz developed Glatopa in collaboration with Massachusetts-based Momenta Pharmaceuticals for treating patients with relapsing forms of MS.
“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,” Sandoz US President Peter Goldschmidt said in a statement.
Copaxone has been Teva's best-selling specialty drug since the FDA approved it 1996. The drug is sold in more than 50 countries, and generated sales totaling $4.8 billion worldwide in 2013.
Anticipating the generic competition for its blockbuster drug, Teva got FDA approval last year for a new concentrated version of Copaxone, called Copaxone 40mg/mL, which is administered three times a week as opposed to the original 20-milligram version taken once a day.
“Healthcare 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 Dr. Janet Woodcock, 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 as safe and effective as the brand name product.”
Sandoz has not disclosed when Glatopa will be available or what it will cost. The average cost for a one-month supply of the 20-milligram version of Copaxone is more than $6,000.
