“This is probably old news for you, but the FDA licensed a generic version of glatiramer acetate last week. The excerpts from the press article below cover the most important issues.”
…… The generic version of the MS drug Copaxone will be sold under the brand name Glatopa by the Sandoz division of Switzerland’s Novartis AG, which signed an agreement with Cambridge-based Momenta to market the generic…..
….. Glatopa was approved as a “substitutable generic” for patients taking Copaxone, an injectable sold by Israel’s Teva Pharmaceutical Industries Ltd. for MS, a degenerative disease of the central nervous system. “Given its complexity, we reviewed additional information to make sure the generic product is as safe and effective as the brand-name product,” said Janet Woodcock, director of the Food and Drug Administration’s drug evaluation unit……
….. Sandoz and Momenta have not disclosed when they will launch Glatopa commercially in the United States or how it will be priced in relation to Copaxone, which competes with such MS drugs as Avonex from Biogen Inc. of Cambridge and Rebif from EMD Serono Inc. of Rockland…..
….. The list price for a year’s worth of Copaxone, which is injected daily, is more than $60,000 per patient. Insurers cover the bulk of the cost for most patients…….
…… “We won’t discuss our pricing strategies publicly ahead of launch but our general goal, as always, would be to offer patients and payers a real alternative to the originator,” said Julie Masow, a spokeswoman for Novartis…..
….. A long-running patent dispute pitting Teva against Sandoz and Momenta is working its way through the federal courts, but it’s not clear if that will delay the launch….