Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz® (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.
“For people who live with a chronic condition, seemingly small adjustments to formulations can have a significant improvement on quality of life,” said Florian Bieber, Global Head Biopharmaceuticals Development, Sandoz. “Today’s positive opinion from the CHMP brings us closer to providing a treatment choice to patients that offers increased convenience and a reduction in injection volume.”
As part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL2 with the 100 mg/mL (HCF). The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.
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