USFDA nod to citrate free high concentration formulation of biosimilar Hyrimoz injection: Sandoz
Sandoz intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023.;
Basel: Sandoz has announced that the US Food and Drug Administration (USFDA) has 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 intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023.
“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” said Keren Haruvi, President, Sandoz Inc., Head of North America.
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