Sandoz Launches Hyrimoz® High-Concentration Formulation in US Immunology Space

03 July 2023 | Monday | News

Sandoz, a global leader in generic pharmaceuticals and biosimilars, announced that the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab-adaz) injection will be available in the United States starting July 1.
Image Source | Public Domain

Image Source | Public Domain

  • Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) biosimilar offers US patients reduced injection volume in citrate-free formulation

  • As one of the only adalimumab HCF biosimilars approved in the US, Hyrimoz HCF expands access for millions of people with serious inflammatory diseases

  • Launch builds upon Sandoz global biosimilars legacy, with Hyrimoz 50 mg/mL having nearly 120 million days of patient experience across 41 countries1

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.2

Please see detailed indications at the end of this announcement.

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

“Sandoz has a long history of developing and marketing biosimilars that generate healthcare savings and enhance competition that drives innovation in the market. We are pleased to continue this legacy in the US with Hyrimoz, which offers another treatment option for those who need adalimumab but might have previously been unable to access or afford this critical medicine.”

Hyrimoz HCF offers a 50% 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° viewing window for visual feedback.

Sandoz has established Sandoz One Source for Hyrimoz, a robust patient support program that provides educational, reimbursement and affordability support.

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