The first generic formulation of the multiple sclerosis drug glatiramer acetate has been approved by the Food and Drug Administration, despite efforts by Copaxone manufacturer Teva to delay the approval of a generic version of the drug.
But it is unclear when the generic will be available.
The approved generic, in a 20 mg/mL daily injection, is manufactured by Sandoz, the FDA announced in a statement issued on April 16. The statement was accompanied by a letter from the FDA denying Teva’s citizen’s petition requesting that the FDA not approve generic versions of the drug “unless and until” certain conditions were met, including the conduct of extensive studies showing generic versions are bioequivalent to Copaxone . This was the eighth petition submitted by Teva, according to the FDA’s letter.
The FDA’s statement announcing the approval said that the agency “applies the same rigorous and reliable standards to evaluate all generic drug products. As needed, the agency requires appropriate information to demonstrate sameness for complex active ingredients, such as glatiramer acetate. For this approval, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of glatiramer acetate.”
Before approval of this 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, director of the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement.
In a statement , Sandoz said it will market the generic form as Glatopa . A spokesperson said that the company cannot comment on plans for launching Glatopa.
In January, the U.S. Supreme Court overturned a federal circuit court’s judgment that had said that a patent for Copaxone 20 mg/mL was invalid because Teva’s listing of the molecular weight of its active ingredient as “5 to 9 kilodaltons” was fatally indefinite, sending it back to the U.S. Court of Appeals for the Federal Circuit for further review.
“Given the pending decision from the U.S. Court of Appeals for the Federal Circuit, any companies that launch a generic version of Copaxone would do so at risk,” a Teva spokesperson said in response to a request for a comment.
Approved in 1996, glatiramer acetate is indicated for relapsing forms of MS; the 20 mg/mL dose is administered once a day. Teva also markets a 40 mg/mL dose that is administered three times a week.
