FDA Approves Humira Biosimilar Hyrimoz

The FDA approved a citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz; Sandoz) injection, a biosimilar to Humira (adalimumab).

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.[1]

Sandoz, a division of Novartis, 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,” Keren Haruvi, President, Sandoz, Head of North America, said in a company news release. “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.

References

1. Hyrimoz. Prescribing Information. Available at: Hyrimoz_Highlights_Prescribing_Information.pdf (sandoz.com)