FDA approves Yuflyma biosimilar for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.- Celltrion USA
Celltrion USA announced that the FDA has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira (adalimumab) biosimilar.
The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
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.
Celltrion is also seeking an interchangeability designation from the U.S. FDA for Yuflyma, which is tentatively expected Q4 2024. Following the launch of 40mg/0.4mL, in the U.S. in July 2023, Celltrion additionally plans to launch two different types of dosage forms 80mg/0.8mL, 20mg/0.2mL.
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