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Generic Version of Copaxone, Multiple Sclerosis Drug, Is Approved

April 16, 2015

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 Industries.

The approval of the generic, which was developed by the team of Sandoz andMomenta 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.

“It’s the inverse of what you normally expect when there is competition,” said Dr. Dennis N. Bourdette, chairman of neurology at Oregon Health and Science University. “There’s no apparent reason for the skyrocketing prices of those drugs, aside from that we have no cost controls in this country.”

Dr. Bourdette welcomed the generic, but said its impact would depend on its price. Citing competitive reasons, Momenta and Sandoz declined to say when the generic version would go on sale and how much it would cost.

When there are many generic competitors, prices can drop as much as 90 percent. But when there is only one generic, as is the case so far with Copaxone, the discount to the brand-name product is typically much smaller.

Even though about 10 drugs are now approved to treat multiple sclerosis, none of them has had a generic equivalent with the exception of mitoxantrone, which is not widely used. It is possible that the introduction of generic Copaxone could help keep prices of all the drugs in check.

Multiple sclerosis is a nerve disease that can cause problems like blurred vision and difficulty walking.

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. That is because Copaxone had sales of $4.2 billion last year, accounting for 21 percent of Teva’s revenue and nearly half its profit.

About $3.1 billion of those sales were in the United States, where Copaxone is the most widely used multiple sclerosis drug, accounting for about 30 percent of prescriptions.

Teva began selling a more concentrated formulation of Copaxone that requires an injection only three times a week instead of once a day and has a longer patent life. It began an aggressive campaign to get patients to switch, calling them and treating them to dinners. It also priced the new version lower than the old one.

About two-thirds of patients using Copaxone have already switched to the new version and might be reluctant to switch to the generic, which is a copy of the original Copaxone and would require them to inject themselves every day again.

Teva has also filed eight petitions with the F.D.A. arguing that Copaxone, known generically as glatiramer acetate, has such a complex composition that it is impossible to copy exactly, and that subtle differences might harm patients. Copaxone is made of four different amino acids linked in chains of various size and sequence. It is not exactly clear how the drug works.

The F.D.A. on Thursday posted a detailed response to Teva’s arguments and sought to assuage any such concerns.

“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,” Dr. Janet Woodcock, the director of the agency’s drug division, said in a statement. Copaxone was first approved in 1996 and sold for about $9,000 a year. Momenta and Sandoz, which is the generic division of Novartis, first applied for approval at the end of 2007 and had hoped to have it before now.

Craig A. Wheeler, the chief executive of Momenta, said the delay, which gave Teva more time to switch patients to the newer version of drug, “certainly gives us a higher hill to climb to bring this product up to what we had hoped for originally.” He said he did not expect many patients taking Teva’s three-times-a-week version to switch back to the once-a-day version, though some insurers might try to bring that about.

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