Novartis division Sandoz application for proposed biosimilar Hyrimoz's high concentration formulation accepted by EMA
Upon approval, the Hyrimoz (100 mg/mL) citrate-free HCF would offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg dosing.
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Basel: Sandoz has announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab) for regulatory review. The application includes all indications covered by the reference medicine*, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis.
Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). The adalimumab reference medicine (Humira*) was first approved with an adalimumab concentration of 50 mg/mL. In 2015, the EMA and US FDA approved Humira HCF, which contains adalimumab at a concentration of 100 mg/mL.
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