Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation
Shots:
- The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab)
- Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was presented at EADV 2024
- Yuflyma is a high-concentration (100mg/mL), citrate-free Humira formulation that is available in 20mg, 40mg, & 80mg doses for injection in a prefilled syringe or an autoinjector pen
Ref: Prnewswire | Image: Celltrion
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