FDA Approves Celltrion’s Yuflyma as Humira Biosimilar for 8 Disease States

The FDA has approved adalimumab-aaty (Yuflyma; Celltrion USA), a high concentration and citrate-free formulation of adalimumab (Humira; Abbvie) biosimilar.

The 100 mg/mL strength was approved for the treatment of 8 conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Biosimilar spelled on blocks | Image credit: lexiconimages - stock.adobe.com

“[Adalimumab-aaty] offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients. It represents a key treatment option in patient care and patient choice,” Tom Nusbickel, chief commercial officer at Celltrion USA, said in a press release.

Adalimumab-aaty is the second anti-tumor necrosis factor (TNF) α biosimilar approved for use in the United States, according to the press release. The drug features a pre-filled syringe and autoinjector administration to meet different needs and preferences of patients.

The approval comes after comprehensive data were submitted to the FDA, including analytics, preclinical data, and clinical studies. The data demonstrated that adalimumab-aaty is comparable to the reference product in efficacy, safety, pharmacokinetics, and immunogenicity for up to 24 weeks and 1 year after treatment. The most common adverse effects in clinical trials included upper respiratory infections, sinusitis, injection site reactions, headache, and rash.

Limitations of use include individuals who have lost response to or were intolerant to TNF blockers. Investigators have not established effectiveness in this population.

According to the safety information, patients who are treated with adalimumab-aaty are at an increased risk of serious infections that could lead to hospitalization or death. Patients who experience these infections are typically taking a concomitant immunosuppressant, including methotrexate or corticosteroids. The drug should be discontinued if a serious infection or sepsis is present. Infections include active tuberculosis (TB), including reactivation of latent TB; invasive fungal infections, including pneumocystis, candidiasis, and histoplasmosis; and bacteria, viral, and other infections, including legionella and listeria.

“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. 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,” Jonathan Kay, associate director of the MD/PhD program at the University of Massachusetts Chan Medical School, said in the press release.

Adalimumab-aaty will be available to patients in the United States starting July 2023 in the 40 mg/0.4 mL dosage, and the company will also seek an interchangeability designation from the FDA, which is tentatively expected in the fourth quarter of 2024.

The drug was the first proposed high-concentration, low-volume, and citrate-free adalimumab biosimilar to received approval from the European Commission. Additionally, Celltrion USA plans to launch 2 different dosages, 80 mg/0.8 m and20 mg/0.2 mL.

Reference

Celltrion USA announces US FDA approval of Yuflyma (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar. News release. Business Wire. May 24, 2023. Accessed May 25, 2023. 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