On January 31, 2023, Amjevita™ (adalimumab-atto) entered the U.S. market as the first biosimilar of Humira® (adalimumab), after receiving approval in September 2016. Amjevita will be available in a low-concentration, citrate-free formulation (40 mg/0.8mL and 20mg/0.4mL) in prefilled syringes and for autoinjectors.  There will be two different pricing options, the first at a list price (wholesale acquisition cost) that is a 5% discount compared to Humira, and the other at a 55% discount.  The various discounts are offered to accommodate different rebating and discounting practices by payers and pharmacy benefit managers.

Amjevita is the first Humira biosimilar to enter the U.S. market, with at least seven additional biosimilars likely to launch this year based on settlement agreements.  Cyltezo® (adalimumab-adbm), the first biosimilar approved as interchangeable with Humira, with the possibility for automatic substitution at the pharmacy, will launch as early as July 1, 2023.  Hadlima™ (adalimumab-bwwd), the first biosimilar approved as a high-concentration, citrate-free formulation, will be available as early as July 1, 2023.  The high-concentration formulation of Humira accounts for over 80% of its prescriptions.



    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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