Earlier this month, FDA approved Boehringer Ingelheim’s high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab). CYLTEZO was first approved in the US in 2017 and later approved in the US as an interchangeable biosimilar to Humira in October 2021. A lower concentration version of CYLTEZO (50 mg/mL) has been on the market since July 2023. According to BI, the high-concentration formulation (100 mg/mL) “is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira® under the brand name CYLTEZO® and at an 81% discount to Humira as the unbranded product Adalimumab-adbm.” The FDA has not yet granted an interchangeability designation for the 100 mg/mL formulation, which was approved with labeling removing all references to interchangeability. CYLTEZO is approved for use in the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, Crohn’s Disease, and Ulcerative Colitis.
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