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).

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 Bloomberg, the company used a 24-hour support hotline in the United States to persuade Copaxone 20 mg/mL users to switch to a more concentrated version of the drug-a 40-mg/mL dose-that requires fewer injections per week (three injections per week vs. one injection per day with the older formulation). The new formulation has patent protection until 2030, and while the new version might be more convenient for patients (a factor which could drive better adherence), the efficacy of the 40 mg/mL version is the same. The new version has a lower price than the older formulation, and according to a Teva spokesperson, the data through April 3, 2015 show that the current patient conversion rate (from the old formulation to the new version) is 66.8%.

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 reduce operating income by $30 to $50 million per month, as per Reuters.

Teva won a patent infringement lawsuit against Momenta/Sandoz in 2012, but the US Court of Appeals for the Federal Circuit reversed the district court ruling on the patent in 2013, resulting in the drug's patent protection being shortened. The US Supreme Court later ruled on January 20, 2015 that a federal appeals court had erred in invalidating the patent covering Copaxone.

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.”

Sources:
MomentaFDA