FDA Approves Sandoz’s Generic Version of Teva’s CopaxoneBy
Sandoz, a Novartis company, have received US Food and Drug Administration (FDA) approval for Glatopa, a generic version of Teva’s Copaxone (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis (MS) therapy .Glatopa is the first generic version of Copaxone approved by the FDA.
Glatopa, developed in collaboration with Momenta and produced 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 (MRI) features consistent with MS.
In 2014, Copaxone had revenues of $4.3 billion. The US Orange Book patents covering Copaxone (20 mg) expired in May 2014. To combat generic-drug incursion for Copaxone, Teva developed a new formulation, Copaxone 40 mg/mL, which is administered three times a week. The new formulation, which was approved by the FDA in January 2014, allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS.
Sandoz’s strategy in generics is to develop what it terms as complex differentiated generics, which represent more than 40% of its global portfolio, according to company information.