FDA approves ‘high-concentration, citrate-free’ Yuflyma as ninth Humira biosimilar
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The FDA has approved Celltrion USA’s Yuflyma as the ninth biosimilar to adalimumab for all eligible indications of the reference product, and the latest in a flood of biosimilars cleared for 2023 release in the United States.
Yuflyma (adalimumab-aaty, Celltrion USA) is a high-concentration (100 mg/mL), citrate-free biosimilar to the world’s top-selling Humira (adalimumab, AbbVie), approved for patients with adult Crohn’s disease, ulcerative colitis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and hidradenitis suppurativa. Yuflyma will be offered as a pre-filled syringe and autoinjector to meet patients’ different needs.
“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,” Jonathan Kay, MD, of the University of Massachusetts Chan Medical School, said in the release. “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.”
The FDA based its approval on a review of a comprehensive data package for adalimumab-aaty, including analytical, preclinical and clinical studies, which demonstrated that the therapy is similar to its reference product with regard to efficacy, safety, pharmacokinetics and immunogenicity up to 24 weeks and 1 year after treatment.
The prescribing information includes warnings about serious infections and malignancy risks, including lymphoma, associated with the drug. The most common adverse reactions included infections, injection site reactions, headache and rash.
“Yuflyma offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients,” Tom Nusbickel, chief commercial officer at Celltrion USA, said in the release. “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.”
Celltrion USA noted adalimumab-aaty will be available in the U.S. beginning July 2023. Additionally, the company tentatively expects its product to be granted interchangeability designation from the FDA in the fourth quarter of 2024.
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