Amgevita (adalimumab) Biosimilarity to Humira | Amgen

What’s behind amgevita®

AMGEVITA® biosimilarity to Humira® based on a totality of evidence

AMGEVITA® was the first approved Humira® biosimilar by the EC and FDA based on a robust data package.


Rheumatold arthritis1 and plaque psoriasis2
Two randomised, double-blind bioequivalence trials


Clinical pharmacology3


In vivo4,5
Toxicokinetic parameters in monkeys
Analytical characterisation5,6
Approximately 100 different analytical characterisation assays were assessed to prove structural and functional similarity to Humira®
EC: European Commission; FDA: Food & Drug Administration; PD: Pharmacodynamics; PK Pharmacokinetics.
  1. Cohen S, et al. Ann Rheum Dis. 2017;76:1679–87.
  2. Papp K, et al. J Am Acad Dermatol. 2017;76:1093–102.
  3. Kaur P, et al. Ann Rheum Dis. 2017;79;526–33.
  4. AMGEVITA® European Public Assement Report, January 2017.
  5. ABP 501: Background information for the arthritis advisory committee. Submitted to the FDA by Amgen, July 2016.
  6. European Commission Approves AMGEVITA® (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases. Amgen press release, 23 March 2017. Available at: Last accessed May 2020.
Humira® is a registered trademark of AbbVie Inc.

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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.