On 01 May 2024, Boehringer Ingelheim announced that the FDA approved its high-concentration, citrate-free formulation of Cyltezo® (biosimilar to Abbvie’s Humira® (adalimumab)), for multiple chronic inflammatory diseases.
BI now has approvals for the high (100 mg/mL) and low (50 mg/mL) concentration formulations of Cyltezo®, the latter on market since July 2023. The newly approved high-concentration formulation of Cyltezo® is available in pre-filled syringes and autoinjectors. Cyltezo® is priced 5% lower than Humira® and the unbranded biosimilar Adalimumab-adbm is offered at a price of 81% less than Humira®.
Alvotech and Teva’s Simlandi® received FDA approval on 24 February 2024 as the first high-concentration, citrate-free biosimilar to Humira® to be granted interchangeable status by the FDA. FDA has also approved Samsung Bioepis’ Hadlima, Amgen’s Amjevita, Sandoz’s Hyrimoz, and Celltrion’s Yuflyma, as high concentration formulations.