Clinical Pharmacology | Amgevita Phase 1 Study | Amgen

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What’s behind amgevita®
MAKES THE DIFFERENCE

PHASE 1 STUDY

Bioequivalent to Humira® in phase 1 clinical pharmacokinetic study

AMGEVITA® was shown to be bioequivalent to Humira® for PK parameters1*
  • Mean serum concentration versus time profiles for AMGEVITA® and Humira® in healthy adults1*
  • Ratio of adjusted least squares geometric means (90% CI)1
AUCinf: Area under the concentration curve versus time from zero to infinity; AUClast: Area under the concentration curve from the time of dosing to the last measurable concentration; CI: Confidence interval; Cmax: Maximum serum concentration; PK: Pharmacokinetic.
*A randomised, single-blind, single-dose, 3-arm, parallel-group study to determine PK equivalence of AMGEVITA® and Humira® in healthy subjects. The primary objective was to evaluate bioequivalence of AMGEVITA® and Humira® in terms of AUCinf and Cmax (equivalence criteria: 90% CI for geometric mean ratio within 0.80–1.25).
1. Kaur P, et al. Ann Rheum Dis. 2017;79;526–33.

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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.