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Sandoz Gets FDA Approval For Biosimilar Hyrimoz High-concentration Formulation

March 21, 2023 — 11:16 am EDT

Written by RTTNews.com for RTTNews ->

(RTTNews) - Sandoz, a Novartis (NVS) division, said Tuesday that that the US Food and Drug Administration approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection.

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis.

Sandoz plans to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023.

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