US FDA approves high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable* biosimilar to Humira®
"Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings."
- "Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings."
- "The flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicines."
- "We welcome the introduction of this additional formulation to expand the array of options available to our community."
- The FDA approval is based, in part, on data from clinical trial VOLTAIRE-HCLF , a Phase I clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm.