Novartis’ Sandoz receives positive CHMP opinion for citrate-free HCF adalimumab

Novartis’ Sandoz announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation, or HCF, of its biosimilar Hyrimoz, or adalimumab. The authorization includes all indications covered by the reference medicine: rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis and uveitis. "Upon approval, the adalimumab citrate-free HCF (100 mg/mL) formulation will offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg/mL dosing. The HCF formulation will have the same auto-injector as currently offered, aiming for an enhanced yet familiar patient experience," the company stated.