Sandoz Launches Generic Version of Teva’s Copaxone
Sandoz, the generics arms of Novartis, has launched in the US Glatopa, a generic version of Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy. Sandoz had received US Food and Drug Administration approval for the drug earlier this year, in April 2015.
Glatopa, developed in collaboration with Momenta and produced ly 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.
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.