Sandoz, a global leader in generic pharmaceuticals and a  subsidiary of Novartis, has received approval from the US Food and Drug Administration (FDA) for Glatopa, the first generic version of Teva's multiple sclerosis therapy Copaxone (glatiramer acetate injection).

The once-daily medicine, Glatopa, developed in association with Momenta Pharmaceuticals and produced entirely in the US, is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging  features consistent with MS.

MS is a debilitating disease affecting about half a million individuals in the US alone; only half of those diagnosed are currently treated.

"Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy," said Peter Goldschmidt, president of Sandoz US.  

"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," said Goldschmidt.

Sandoz is the global leader in complex differentiated generics, which represent more than 40% of its global portfolio, and one of the top two global generics companies by net sales.

Fighting MS, together with other CNS disorders, is central to the Novartis mission, and Sandoz's Glatopa joins a broad MS portfolio including two approved therapies and one late-stage development compound.