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# Celltrion Biosimilar Copy of Humira Approved
- URL: https://www.fdaweb.com/celltrion-biosimilar-copy-of-humira-approved/
- Published: 2023-05-24T12:00:00.000Z
- Updated: 2026-09-14T18:34:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154523

FDA has approved a Celltrion BLA for Yuflyma (adalimumab-aaty), biosimilar copy of AbbVie’s Humira. The high-concentration (100mg/mL) and citrate-free formulation is approved for treating eight conditions — rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Approval 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 says. The company says it is also seeking an interchangeability designation from the agency, with a decision expected next year in the fourth quarter.