BioCentury
ARTICLE | Clinical News

Glatopa glatiramer acetate regulatory update

April 20, 2015 7:00 AM UTC

FDA approved an ANDA from Novartis’ Sandoz unit and Momenta for once-daily Glatopa glatiramer acetate to treat relapsing forms of multiple sclerosis (MS). The selective major histocompatibility complex class II (MHCII) modulator is the first FDA-approved generic version of Copaxone from Teva Pharmaceuticals Industries Ltd. (NYSE:TEVA, Petah Tikva, Israel). Glatopa was approved as a 20 mg/mL injection. Teva is converting patients from once-daily Copaxone to a thrice-weekly formulation of the drug, which has patent protection until 2030. ...