FDA Approves Yuflyma, the Ninth Adalimumab Biosimilar

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Celltrion USA has announced the recent US Food and Drug Administration (FDA) approval of Yuflyma (adalimumab-aaty), a citrate-free and high-concentration (100mg/mL) adalimumab (Humira) biosimilar.¹ Yuflyma is approved to treat 8 inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. Yuflyma is the first high-concentration and citrate-free adalimumab biosimilar to gain European Union marketing authorization. As part of the adalimumab biosimilar boom, Yuflyma is the 9th FDA-approved adalimumab biosimilar available to US patients.

Yuflyma will be available as pre-filled syringes and an autoinjector pen to meet the different preferences and needs of each patient. Celltrion has also applied for interchangeability designation from the FDA for Yuflyma, and a decision is expected in Q4 of 2024. An interchangeable biosimilar meets additional requirements outlined by the FDA, and usually requires extra clinical studies to prove there is no additional risk or reduced drug effectiveness if a patient switches between the interchangeable biosimilar and the reference drug.

According to Celltrion, “the approval of Yuflyma was based on a comprehensive data package of analytical, preclinical, and clinical studies, demonstrating that Yuflyma is comparable to the reference product in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and one year following treatment.”

Yuflyma is hoping to join Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as an autoinjector adalimumab biosimilar with interchangeability designation. Cyltezo received interchangeability designation in October of 2021, and its autoinjector pen was also approved this week.

Yuflyma was the world’s first proposed high-concentration, low-volume, and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL, in the US in July of 2023, Celltrion additionally plans to launch 2 different types of dosage forms: 80mg/0.8mL and 20mg/0.2mL. Yuflyma is Celltrion’s 5th biosimilar and 2nd anti-TNF biosimilar approved in the US.

Reference

1. Celltrion USA announces US FDA approval of Yuflyma (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar. Healthcare Celltrion. Published May 24, 2023. Accessed May 25, 2023. https://www.celltrionhealthcare.com/board/en_newslist/102