Amgevita (adalimumab) Biosimilarity to Humira | Amgen

You are leaving Amgevita.EU website and entering another Amgen website

You are leaving Amgevita.EU website and entering another Amgen website

You are now leaving Amgevita.EU
Amgen does not endorse or accept liability for sites controlled by third parties

Return to previous page Continue

Countries ▼

What’s behind amgevita®
MAKES THE DIFFERENCE

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.

CLINICAL STUDIES

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

PHASE 1 STUDY

Clinical pharmacology3
PK/PD
►

PRE-CLINICAL STUDIES

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: www.amgen.com/media/news-releases/2017/03/european-commission-approves-amgevita-biosimilar-adalimumab-for-the-treatment-of-certain-inflammatory-diseases/. Last accessed May 2020.
Humira® is a registered trademark of AbbVie Inc.

Home

SmPC

footerbg

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.

The information contained in this website is for European healthcare professionals only

I understand and confirm I am an EU healthcare professional
Read more >
I am not an EU healthcare professional
Read more >
▼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.