The European Commission approves Hyrimoz (adalimumab biosimilar) high-concentration formulation
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that the European Commission (EC) granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz (adalimumab)
The approval includes all indications covered by the reference medicine: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.
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.
As part of the comprehensive submission package to the European Marketing Authorization, 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.Recently, Food and Drug Administration (FDA) also approved the citrate-free HCF of Hyrimoz® (adalimumab-adaz) injection.
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