Sandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab biosimilar
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today 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.
Sandoz is committed to helping millions of patients access biologic medicines sustainably in areas including oncology and immunology. With a strong portfolio of eight marketed biosimilars and a further 15+ in various stages of development, Sandoz has an unparalleled heritage and extensive expertise in the development, manufacturing and delivery of biosimilar medicines to patients and the healthcare community worldwide.