
FDA Approves Generic Version of Multiple Sclerosis Drug Copaxone
FDA approved the first generic version of Copaxone (glatiramer acetate), a widely prescribed drug to treat multiple sclerosis. The generic version of the medication, called Glatopa, will be marketed by Sandoz and Momenta. Glatopa is the first generic indicated for the treatment of patients with relapsing-remitting forms of multiple sclerosis (RRMS).
FDA approved the first generic version of Copaxone (glatiramer acetate), a widely prescribed drug to treat multiple sclerosis. The generic version of the medication, called Glatopa, will be marketed by Sandoz and Momenta. Glatopa is the first generic indicated for the treatment of patients with relapsing-remitting forms of multiple sclerosis (RRMS).
Although approved by FDA, the generic version of Teva’s blockbuster drug will not immediately launch, as Teva may still hold patent rights to Copaxone until September 2015. Further, Teva’s aggressive marketing tactics may affect generic Copaxone uptake. According to
Momenta will receive $10 million from Sandoz as a result of the FDA approval of the ANDA, and will get another $10 million upon first commercial sale of the product. It will also be eligible to receive up to $140 million in milestone payments upon the achievement of certain U.S. regulatory, commercial and sales-based milestones for Glatopa. "The FDA approval of the ANDA for once daily Glatopa further validates Momenta's approach of using innovative physicochemical and biologic characterization to gain approval of complex generics, biosimilars, and novel drugs, and advances Momenta's goal of expanding access to high quality, more affordable medicines," said Craig Wheeler, president and CEO, Momenta Pharmaceuticals, in a press release.
Copaxone has record annual revenues of $4.3 billion, which represents approximately half of Teva’s revenue. A generic entrant like Momenta/Sandoz’s has the potential to offset Teva’s book of business drastically: Teva has estimated that generic entry of Copaxone could
Teva
Teva has also argued that glatiramer acetate is too hard to replicate, implying the quality of any generic will be subpar. FDA’s Janet Woodcock assuaged those fears, saying in a press release that “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.”
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