Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA.
Sandoz, a global leader in generic and biosimilar medicines, 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.
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. Hyrimoz HCF will have the same auto injector as Hyrimoz 50 mg/mL, aiming for an enhanced yet familiar patient experience.
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