FDA Approves High-Concentration, Citrate-Free Biosimilar Adalimumab-aaty

The US Food and Drug Administration (FDA) approved adalimumab-aaty (Yuflyma), a high-concentration (100 mg/mL) and citrate-free biosimilar version of adalimumab (Humira), according to a statement from Celltrion USA. The drug, which is the first high-concentration and citrate-free adalimumab biosimilar to receive European Commission approval in Europe, will be available via a pre-filled syringe as well as an autoinjector to meet patients’ different preferences and needs.

The approval was based on a comprehensive assortment of preclinical, clinical, and analytical studies which showed adalimumab-aaty was comparable to the reference drug regarding safety, efficacy, immunogenicity, and pharmacokinetics following treatment initiation.

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication,” stated Professor Jonathan Kay of UMass Chan Medical School. “The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy.”¹

Adalimumab-aaty is a recombinant fully human anti-tumor necrosis factor α (anti-TNFα) monoclonal antibody and is approved for a variety of inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, juvenile idiopathic arthritis, ankylosing spondylitis, hidradenitis suppurativa, and plaque psoriasis. It is the fifth biosimilar approved for use in the United States produced by Celltrion USA.

Patients receiving the biosimilar are at an increased risk for developing serious infections, particularly for those that are receiving concomitant immunosuppressants including corticosteroids and methotrexate.

Adalimumab-aaty will be available in 40 mg/.4 mL dosage form to patients beginning in July 2023. Celltrion also plans to launch 80 mg/.8 mL and 20 mg/.2 mL in the future.

“Yuflyma offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients,” stated Tom Nusbickel, Chief Commercial Officer at Celltrion USA. “It represents a key treatment option in patient care and patient choice. As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to expand the availability of high-quality biosimilars for U.S. patients.”¹

References

1. ^{Celltrion USA announces U.S. FDA approval of Yuflyma® (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira® (adalimumab) biosimilar. Business Wire. (2023, May 24). https://www.businesswire.com/news/home/20230524005407/en/Celltrion-USA-Announces-U.S.-FDA-Approval-of-Yuflyma%C2%AE-adalimumab-aaty-a-High-Concentration-and-Citrate-Free-Formulation-of-Humira%C2%AE-adalimumab-Biosimilar}