Shots:
- FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes
- Designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. active plaque PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was shared at EADV 2024
- Yuflyma is a high-concentration (100mg/mL), citrate-free formulation of Humira that will be available at a reduced WAC list price of $948/syringe, effective immediately
Ref: Prnewswire| Image: Celltrion| Press Release
Related News:- Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation
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