Sandoz wins first FDA nod for generic of Teva MS flagship Copaxone
- The FDA has approved the ANDA for Glatopa, the substitutable generic for Copaxone (glatiramer acetate for injection) for treatment of remitting relapsing multiple sclerosis (RRMS)
- Under a partnership agreement with Momenta Pharma, Glatopa will be commercialized by Sandoz.
- The agreement also stipulates that Momenta is eligible to receive up to $140 million in milestone payments, based on achieving certain commercialization and sales-related goals.
As with other ANDAs, the basis for approval of Glatopa was therapeutic equivalence in terms of Glatopa having the same ingredients, route of administration, strength, and dosage form (20 mg) as Copaxone.
This approval represents an important milestone for the generics industry in general. In May 2014, Teva tried to block the FDA from approving generic Copaxone, which has about $20 billion per year in revenues. The appellate court ruled against Teva before the U.S. Supreme Court reversed the decision, giving Teva some more months of patent exclusivity and sending the case back to lower courts.
The introduction of a generic substitutable Copaxone equivalent will be greeted enthusiastically by payers, because Copaxone costs on average $60,000 per year, per patient, and because many patients with RRMS rely on Copaxone to address the symptoms of their disease.