According to a May 1, 2024 press release, the high-concentration (100 mg/mL), citrate-free formulation of Boehringer Ingelheim’s Cyltezo^® (adalimumab-adbm) was approved by the FDA on May 1 as interchangeable with AbbVie’s Humira^® (adalimumab) to treat multiple chronic inflammatory diseases.  Cyltezo^® was initially approved as a low-concentration biosimilar in August 2017 and as an interchangeable in October 2021.  The low-concentration, citrate-free formulation of Cyltezo^® has been available since July 1, 2023 at a 5-7% discount to Humira^®, and a second unbranded version was launched in October 2023 at an 81% discount to Humira^®.  According to Boehringer Ingelheim the high-concentration Cyltezo^® interchangeable will be available at the same discounts.  Notably, the high-concentration adalimumab formulation accounts for about 80% of total Humira^® prescriptions.  This is the second FDA approval for a high-concentration interchangeable of Humira^®, following Alvotech and Teva’s Simlandi^® (adalimumab-ryvk), which has yet to launch in the U.S.

According to a Samsung Bioepis report, the Humira^® biosimilar market share was about 4% of the total adalimumab market as of February 2024.  On April 1 it was reported that CVS Caremark dropped Humira^® from some of its largest formularies which resulted in the adalimumab biosimilar market share increasing to about 36% of the total adalimumab market one week following the announcement.

Humira^® had U.S. sales of nearly $12.2 billion in 2023.

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The authors would like to thank April Breyer Menon for her contributions to this article.