Shots:

• The P-III VOLTAIRE-X interchangeability study involves assessing the PK similarity- efficacy- immunogenicity- and safety profiles between patients with mod. to-sev. chronic PsO receiving Humira (40mg/0.8mL) continuously vs those who switched several times b/w Cyltezo and Humira
• Results: @32wks. the study met its 1EPs- supporting Cyltezo’s application as an interchangeable biosimilar to the reference product
• The study showed that switching b/w Cyltezo (adalimumab-adbm) and Humira resulted in similar PK- efficacy- immunogenicity- and safety. The company has submitted sBLA for Cyltezo for designation as an interchangeable biosimilar to Humira with an anticipated PDUFA date in Q4’21

  Ref: Boehringer Ingelheim | Image: Boehringer Ingelheim