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.
A survey of gastroenterologists, dermatologists, and rheumatologists found Amjevita had the most recognition, followed by Cyltezo, the only interchangeable biosimilar on the US market.
After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.