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Sandoz's Citrate-Free HCF Adalimumab Biosimilar Receives CHMP Approval

Friday, February 10, 2023

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a favorable opinion for marketing authorization for a citrate-free high-concentration formulation (HCF) of Sandoz's biosimilar Hyrimoz® (adalimumab).

The authorization covers all indications covered by the reference drug*, including uveitis, ulcerative colitis, plaque psoriasis, and rheumatoid arthritis.

Once approved, the HCF formulation will provide patients with a more convenient and reduced injection volume while still providing them with a familiar experience.

A monoclonal human immunoglobulin G1 (IgG(1)) antibody called adalimumab fights tumor necrosis factor-alpha (TNF-a).

Adalimumab at a dosage of 50 mg/mL was used when the adalimumab reference drug (Humira®*) was initially approved. Adalimumab, in Humira® HCF, was authorized by the EMA and US FDA in 2015 at a concentration of 100 mg/mL.

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