Source: Business Day
The Food and Drug Administration on Thursday approved the first generic substitute for Copaxone, a widely used drug for multiple sclerosis and the biggest selling product for Teva Pharmaceutical.
The approval of the generic, which was developed by the team of Sandoz and Momenta Pharmaceuticals — could bring some price competition to the market for multiple sclerosis drugs. Prices for those drugs have tripled in the last several years, to over $60,000 a year, even as more products have come to market, seemingly defying the laws of economics.
It was not immediately clear when the generic version would go on sale and how much it would cost. Teva may still have a patent that extends until September.
Teva is the largest manufacturer of generic drugs in the world and has often challenged the tactics used by brand-name drug companies to stave off generic competition.
But with Copaxone, which is a brand-name product, Teva has resorted to many of those same tactics.
It began selling a more concentrated formulation of Copaxone that requires an injection only three times a week instead of once a day, and it priced the new version lower than the old one to encourage people to switch.
About two-thirds of patients using Copaxone have already switched to the new version, which has patent protection that lasts for many more years. It might now be hard for insurers to get patients to switch to the lower-priced generic, which is a copy of the original Copaxone and requires injections every day.
Teva has also filed petition after petition with the F.D.A. arguing that Copaxone, known generically as glatiramer acetate, has such a complex composition that it is impossible to prove a generic is an exact copy and that subtle differences might harm patients.
In announcing the approval on Thursday, the F.D.A. sought to assuage any such concerns.
“Health care professionals and patients can be assured that F.D.A.-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” Dr. Janet Woodcock, the director of the agency’s drug division, said in a statement. “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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