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.

For more information on this and other biosimilars, visit BiologicsHQ.



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



    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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