Sandoz receives FDA nod for biosimilar Hyrimoz citrate-free HCF formulation

Sandoz has obtained the Food and Drug Administration’s blessing for a citrate-free high-concentration formulation of its biosimilar Hyrimoz (adalimumab-adaz) injection.

The adalimumab citrate-free HCF (100 mg/ml) is approved to treat seven indications covered by  AbbVie Biotechnology’s 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 United States on July 1, 2023.

“As one of the first adalimumab high-concentration formulation biosimilars approved in the U.S., 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 U.S., head of North America. “Sandoz has more than two decades of experience researching, developing and bringing biosimilars to markets across the globe. We are excited to continue this leadership by providing patients with another treatment option to help manage their chronic conditions.”

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"Biosimilars are extensively studied, FDA-approved treatments,” said Steve Taylor, president and CEO of the Arthritis Foundation. “There are millions of patients affected by chronic inflammatory conditions that drastically impact their everyday lives. Given the high burden of disease for these conditions, biosimilars are one potential solution for healthcare providers and patients to consider, to ensure patients can take and stay on their medicines to help manage their disease and health outcomes.”

Adalimumab, the active ingredient in Hyrimoz, is an inhibitor of tumor necrosis factor, a protein that is overproduced in certain autoimmune conditions—including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis—causing inflammation and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz targets and blocks the protein that contributes to disease symptoms.

When it launches, Hyrimoz HCF will represent the first launch of a Sandoz biosimilar in the U.S. market in this specific disease space.