First High-Concentration Humira® Interchangeable, Alvotech and Teva’s Simlandi®, Approved in the U.S. | Venable LLP
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.
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The authors would like to thank April Breyer Menon for her contributions to this article.
