USFDA nod to citrate free high concentration formulation of biosimilar Hyrimoz injection: Sandoz

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.

“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.”

The FDA approval was based on a Phase I pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL (HCF). This study met all of the primary objectives, demonstrating comparable PK and showing similar safety and immunogenicity of the adalimumab 50 mg/mL and adalimumab HCF.

"Biosimilars are extensively studied, FDA-approved treatments,” said Steve Taylor, president and chief executive officer, 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.”