FDA approves generic Copaxone for multiple sclerosis
pharmafile | April 17, 2015 | News story | Sales and Marketing | FDA, Sandoz, Teva, glatiramer acetate injection, glatopa
The FDA has signed-off on the first generic version of Copaxone to treat people with relapsing forms of multiple sclerosis (MS).
Glatopa (glatiramer acetate injection) was developed by Sandoz, Novartis’ generics arm, in collaboration with Momenta. The companies had to demonstrate to the FDA that their drug showed ‘sameness for complex active ingredients’ in order to earn the green light.
“Healthcare professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” says Dr Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research.
“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.”
Copaxone is one of Teva’s best-selling drugs and generates around $4 billion in annual sales for the Israeli firm. This was about a fifth of the company’s revenue in 2014, and it stated in financial documents that Copaxone made a “significantly higher percentage contribution to our profits and cash flow from operations”.
Teva has already begun a switching strategy to move patients on to a longer-acting formulation, and it says two-thirds of Copaxone 20 milligram daily injection patients – the dose that is now also available as Glatopa – have been switched.
Teva does have an advantage because as yet it’s not clear when Sandoz will be able to launch Glatopa. A US Supreme Court ruling in Teva’s favour means that the date of the Copaxone patent expiry – set for September 2015 – is still in question.
But Peter Goldschmidt, president of Sandoz US, is still upbeat. “Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy. The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payors a full range of therapeutic options.”
Lilian Anekwe
Related Content
Teva announces positive results from trial of AJOVY for migraine
Teva has announced positive results from the phase 4 PEARL study of AJOVY (fremanezumab), its …
Sandoz launches two new bone disease biosimilars in Europe
Sandoz has announced the European launch of two new bone disease biosimilars. Wyost (denosumab 120 …
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
