The US FDA Approves High Concentration of Boehringer Ingelheim's Cyltezo (Biosimilar, Humira)
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
Related News:- Boehringer Ingelheim Reports the Commercial Availability of Cyltezo, an Interchangeable Biosimilar to Humira
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
