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Sandoz Receives EC Approval For Hyrimoz High-concentration Formulation

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

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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