PRE-CLINICAL STUDY
Similar to Humira® in non-clinical and in vitro studies
AMGEVITA® was shown to be bioequivalent to Humira® for toxicokinetic parameters, with no unexpected toxicity observed with either therapy.1,2
Similar toxicokinetic parameters between AMGEVITA® and Humira® after single and repeated weekly dosing in male and female cynomolgus monkeys1,2*
- In analytical characterization studies, similarity was also shown for the primary mechanisms of action/potency1
*A comparative toxicology study in male and female cynomolgus monkeys receiving 157 mg/kg/week doses of AMGEVITA® and Humira®.
- AMGEVITA® European Public Assement Report, January 2017.
- ABP 501: Background information for the arthritis advisory committee. Submitted to the FDA by Amgen, July 2016.