The FDA has OK'd the first generic version of Copaxone (glatiramer acetate injection) for relapsing-remitting multiple sclerosis (MS), .
Novartis' Sandoz unit, working with Momenta Pharmaceuticals on the product's development, will market the drug as a 20 mg/1 mL injection.
The approval of Sandoz's generic product came despite several attempts by brand name Copaxone drugmaker Teva to prevent generics from coming to market. Teva filed a total of eight citizen petitions to stop several potential generic makers from bringing their versions of the MS bestseller to market.
The Sandoz-Momenta generic is a different product than one developed by the Dutch firm Synthon that was tested in a head-to-head trial against branded Copaxone. Synthon filed for approval of its version last October; no decision has yet been announced.
The FDA stated that it established a "thorough scientific approach" for determining whether the complex active ingredient was indeed the same in the Sandoz-Momenta product as that found in the branded formulation.
"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," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement. But she did not specify what was involved beyond the usual bioequivalence studies required for conventional generic drugs.
Glatiramer acetate, a complex protein mixture, was approved in the 1990s as one of the first drugs shown to be effective at preventing MS relapses and remains a standard first-line treatment in the disease.
The most common adverse reactions with both Copaxone and the new generic agent are skin problems at the injection site, flushing, rash, shortness of breath, and chest pain.