FDA Approves Celltrion’s YUFLYMA (adalimumab-aaty), a Biosimilar to HUMIRA

Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA.  YUFLYMA is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.  As we previously reported, Celltrion entered into an agreement in April 2022 with AbbVie that would allow Celltrion to market its biosimilar to AbbVie’s HUMIRA product.  YUFLYMA is Celltrion’s fifth biosimilar that is approved for use in the U.S., and according to Celltrion it will be available to patients in the U.S. in July 2023.  Celltrion is also seeking interchangeability designation for YUFLYMA, which “is tentatively expected Q4 2024.”

As reflected in the Big Molecule Watch FDA Approval Tracker, this is the ninth biosimilar to HUMIRA to be approved by the FDA, behind Amgen’s AMJEVITA (adalimumab-atto), Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm), Sandoz’s HYRIMOZ (adalimumab-adaz), Samsung Bioepis’s HADLIMA (adalimumab-bwwd), Pfizer’s ABRILADA (adalimumab-afzb), Mylan’s HULIO (adalimumab-fkjp), Coherus’s YUSIMRY (adalimumab-aqvh), and Fresenius Kabi’s  IDACIO (adalimumab-aacf).