Sandoz Receives EC Approval For Hyrimoz High-concentration Formulation

(RTTNews) - Sandoz, the generics and biosimilars division of Swiss drug major Novartis AG (NVS), said Monday that the European Commission granted marketing authorization in the European Union 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 company noted that 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.

Recently, US Food and Drug Administration also approved the citrate-free HCF of Hyrimoz (adalimumab-adaz) injection.

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