On February 23, 2024, the FDA approved Alvotech and Teva’s Simlandi® (adalimumab-ryvk) as biosimilar to and interchangeable with AbbVie’s Humira® (adalimumab)Simlandi® is the tenth Humira® biosimilar to be approved, and the third interchangeable, following Boehringer Ingelheim’s Cyltezo® (low-concentration adalimumab-adbm) and Pfizer’s Abrilada™ (low-concentration adalimumab-afzb).

Simlandi® is the first high-concentration, citrate-free Humira® biosimilar to be designated as interchangeable in the U.S.  An interchangeability designation allows pharmacists to automatically substitute the interchangeable product for the brand name product without consulting the prescriber, subject to state laws.  This approval is significant as the high-concentration formulation accounts for nearly 88% of adalimumab prescriptions.  According to Alvotech and Teva’s press release, Simlandi® will qualify for interchangeable exclusivity for the 40mg/0.4mL injection.  Simlandi®’s pricing and launch date have not yet been announced, although Alvotech and Teva indicated they are ready to launch “imminently.”

According to Samsung Bioepis’s Q4 2023 Biosimilar Market Report, Humira® biosimilars and interchangeables have not yet gained significant market share in their first year on the market, capturing only about 2% of the market.  With a high-concentration adalimumab interchangeable now available, it remains to be seen whether Humira® biosimilar uptake will increase, which, in the case of Simlandi®, will depend on its addition to insurance formularies.

It is noteworthy that in 2024, insurance providers are increasing coverage and preference for Humira® biosimilars, with Cigna preferring Cyltezo® (low-concentration interchangeable), Sandoz’s Hyrimoz® (adalimumab-adaz) and unbranded adalimumab-adaz (both high-concentration biosimilars).  CVS Caremark initially placed Humira® biosimilars on non-preferred tiers but will now prefer Hyrimoz® and unbranded adalimumab-adaz.  Other insurance companies like Mark Cuban Cost Plus prefer biosimilars such as Coherus’s Yusimry™ (adalimumab-aqvh) (low-concentration biosimilar).

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.


    The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

    Subscribe for Future Updates