FDA Approves Adalimumab-adaz High-Concentration Formulation Biosimilar

The FDA has approved a citrate-free high-concentration formulation (HCF) of Sandoz’s biosimilar adalimumab-adaz injection (Hyrimoz) for 7 indications covered by adalimumab (Humira; AbbVie), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.¹

Sandoz intends to launch the biosimilar in the United States on July 1, 2023, according to a press release.¹

“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, MBA, president of Sandoz Inc., head of North America, in the press release.¹

Adalimumab is an inhibitor of tumor necrosis factor, a protein that is overproduced in certain autoimmune conditions, such as rheumatoid arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis. It causes inflammation and tissue destruction in joints, mucosa, or skin. In some cases, the immune system damages the body’s own tissues.¹

The new approval is based on a phase 1 pharmacokinetics bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL HCF. The study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the adalimumab 50 mg/mL and adalimumab HCF.¹

“Biosimilars are extensively studied, FDA-approved treatments,” said Steve Taylor, MBA, president and CEO of the Arthritis Foundation, in the press release. “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 health care providers and patients to consider, to ensure patients can take and stay on their medicines to help manage their disease and health outcomes.”¹

The first biosimilar for Humira was launched in February by Amgen and is expected to be the only adalimumab biosimilar on the market until July.² Although implementing biosimilars in clinical practice can still be a challenge, biosimilars can offer enormous cost savings for patients and the broader health system.

Use of biosimilars in general is sharply increasing. Annual FDA approvals for biosimilars peaked in 2019 with 10 approvals, followed by declines in 2020 and 2021 due to the COVID-19 pandemic. However, 2022 saw that trend rising again,³ and biosimilar approvals for blockbuster drugs such as Humira promise to continue the uptick into 2023.

REFERENCES

1. Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation. News release. Novartis. March 21, 2023. Accessed March 21, 2022. https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoz-adalimumab-adaz-high-concentration-formulation
2. First Humira Biosimilar Launches in the United States. Pharmacy Times. February 1, 2023. Accessed March 21, 2023. https://www.pharmacytimes.com/view/first-humira-biosimilar-launches-in-the-united-states
3. Antrim A. Despite Some Obstacles, Biosimilars Promise Enormous Cost Savings. Pharmacy Times. December 6, 2022. Accessed March 21, 2023. https://www.pharmacytimes.com/view/despite-some-obstacles-biosimilars-promise-enormous-cost-savings