Pre-Clinical Study | Amgevita In Vitro Studies | Amgen

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WHAT'S BEHIND amgevita®
MAKES THE DIFFERENCE

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®.
  1. AMGEVITA® European Public Assement Report, January 2017.
  2. ABP 501: Background information for the arthritis advisory committee. Submitted to the FDA by Amgen, July 2016.

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AMGEVITA® is authorised for the following indications by the European Commission:
AMGEVITA® is an adalimumab biosimilar indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, uveitis and paediatric uveitis.
> See full indication
AMGEVITA® (adalimumab) Summary of Product Characteristics. Available at: www.ema.europa.eu. Last revised March 2020.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.