Sandoz Launches Citrate-Free Adalimumab-Adaz as Biosimilar for Humira

The citrate-free high-concentration formulation (HCF) of adalimumab-adaz (Hyrimoz; Sandoz Inc), a biosimilar injection of adalimumab (Humira; AbbVie), became available in the United States on July 1, according to a Sandoz press release.¹

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Adalimumab-adaz HCF in the 100 mg/mL strength is approved for indications that are no longer covered exclusively for the reference medicine after July 2023, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.¹

“This is an important moment for Sandoz and for the millions of patients living with chronic inflammatory diseases in the [United States]. With this launch, we are entering the US immunology market and continuing to fulfill our commitment to expand access to important medicines for patients,” Keren Haruvi, president of North America at Sandoz, said in a statement.¹

Adalimumab, which is the active ingredient of the drug, tumor necrosis factor inhibitor, a protein that is overproduced in autoimmune conditions, causing inflammation and tissue destruction in the joints, mucosa, or skin.²

The biosimilar has a 50% reduction in injection volume compared to the 50 mg/mL concentration. This can decrease the number of injections required for those who need at least 80 mg/0.8 mL dosing, according to Sandoz.¹

The HCF formulation is citrate-free and uses the same auto-injector that adalimumab-adaz 50 mg/mL uses, called the Sensoready pen. Sensoready is designed as a prefilled pen that is a buttonless injection for self-administration and a 360-degree viewing window for visual feedback.¹

Additionally, the company has established a patient support program that includes educational, reimbursement, and affordability support.¹ The FDA approved the HCF formulation in March 2023.²

The approval was based on a phase 1 pharmacokinetic study that compared the citrate-free drug to the FDA-approved adalimumab. The study met the primary endpoints, demonstrating comparable pharmacokinetics and similar safety and immunogenicity.²

The first biosimilar for adalimumab was launched in February by Amgen, which was the only biosimilar available before July.²

Biosimilars are expected to introduce enormous cost benefits for patients. The market continues to grow rapidly, with approvals peaking in 2019 with 10 biosimilars, followed by a decline in 2020 and 2021 due to the COVID-19 pandemic. In 2022, biosimilar approvals were beginning to increase again, which suggested that the trend will continue to grow.³

Importantly, biologics net spending reached $211 billion in 2019, increasing at a 14.6% compound annual growth rate over the past 5 years.³ One key step to cost savings includes getting payers on board, which include Medicare, Medicaid, and commercial payers. Increasing the number of licensed biosimilars will increase the competitiveness in the market and reduce biosimilar and biologic drug cost.³

References

1. Sandoz to launch Hyrimoz (adalimumab-adaz) high-concentration formulation, marking Sandoz entrance into US immunology space. News release. Novartis. July 1, 2023. Accessed July 5, 2023. https://www.novartis.com/news/media-releases/sandoz-launch-hyrimoz-adalimumab-adaz-high-concentration-formulation-marking-sandoz-entrance-us-immunology-space
2. Antrim A. FDA approves adalimumab-adaz high concentration formulation biosimilar. Pharmacy Times. March 21, 2023. Accessed July 5, 2023. https://www.pharmacytimes.com/view/fda-approves-adalimumab-adaz-high-concentration-formulation-biosimilar
3. Antrim A. Despite some obstacles, biosimilars promise enormous cost savings. December 6, 2022. Accessed July 5, 2023. https://www.pharmacytimes.com/view/despite-some-obstacles-biosimilars-promise-enormous-cost-savings