Sandoz Launches Hyrimoz, Biosimilar to Humira

Sandoz has announced that the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection became available in the United States starting July 1. Hyrimoz HCF (100 mg/mL) is approved to treat all indications no longer covered by the regulatory exclusivity for the reference medicine, Humira (adalimumab), as of July 1, 2023, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.

Hyrimoz HCF offers a 50 percent reduction in injection volume compared to the 50 mg/mL concentration and can decrease the number of injections required for people who need at least 80 mg/0.8 mL dosing. The HCF formulation is citrate-free and uses the same auto-injector as Hyrimoz 50 mg/mL, the Sensoready pen, which is designed with patients in mind. The prefilled Sensoready pen is an ergonomic device with a triangular shape, buttonless injection for self-administration and a 360-degree viewing window for visual feedback.

“This is an important moment for Sandoz and for the millions of patients living with chronic inflammatory diseases in the U.S. With this launch, we are entering the U.S. immunology market and continuing to fulfill our commitment to expand access to important medicines for patients,” said Keren Haruvi, president of Sandoz North America.

References

  1. Sandoz to Launch Hyrimoz (adalimumab-adaz) High-Concentration Formulation, Marking Sandoz Entrance into U.S. Immunology Space. Novartis press release, July 1, 2023. Accessed at www.novartis.com/news/media-releases/sandoz-launch-hyrimoz-adalimumab-adaz-high-concentration-formulation-marking-sandoz-entrance-us-immunology-space.
BSTQ Staff
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