Tuesday, April 04, 2023
Sandoz announced that the European Commission (EC) granted marketing authorisation in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of biosimilar Hyrimoz® (adalimumab).
The adalimumab citrate-free HCF (100 mg/mL) formulation offers a 50 percent reduction in injection volume compared to the 50 mg/ml concentration and potentially decreases the number of injections required for patients who need 80 mg/mL or higher dosing. The HCF formulation is presented in the same auto-injector as currently available to patients, aiming for an enhanced yet familiar patient experience.
The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. In addition, it brings Sandoz one step closer to providing European patients with chronic conditions an additional treatment option that offers increased convenience and a reduction in injection volume.