Erelzi etanercept-szzs regulatory update

FDA approved a BLA from Novartis’ Sandoz unit for Erelzi etanercept-szzs, a biosimilar of autoimmune drug Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.). Erelzi is approved in all indications included on Enbrel’s label. Novartis said “it is too early to speculate” about launch timing or a price for the biosimilar. Etanercept is a recombinant p75 tumor necrosis factor (TNF) receptor linked to the Fc portion of human IgG1 (TNFr:Fc). ...