Shots:
- Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023
- The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration formulations of Cyltezo (adalimumab-adbm)
- Additionally, Cyltezo was approved in Oct 2021 based on the safety & efficacy results incl. from the P-III (VOLTAIRE-X) study investigating the effects of multiple switches between Humira and Cyltezo vs continuous treatment with Humira
Ref: Boehringer Ingelheim | Image: Boehringer Ingelheim| Press Release
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