Lexology February 29, 2024
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...
Today's Sponsors
Today's Sponsor