Skip to Content

Amjevita Approval History

Amjevita (adalimumab-atto) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

The FDA approval of Amjevita was based on analytical, nonclinical, pharmacokinetic and clinical data supporting biosimilarity to the reference product Humira. Safety and immunogenicity were also comparable.

Amjevita is administered via subcutaneous injection.

Amjevita comes with a Boxed Warning alerting health care professionals and patients of the increased risk of serious infections and malignancies. The most common reported side effects include infections (including upper respiratory, sinusitis), injection site reactions, headache, and rash.

Development History and FDA Approval Process for Amjevita

DateArticle
Sep 23, 2016Approval FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira
Jul 12, 2016Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab
Jun 13, 2016Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab
Jan 25, 2016FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501
Nov 25, 2015Amgen's First Biosimilar Biologics License Application for ABP 501 Submitted to FDA
Feb  3, 2015Amgen Announces Positive Top-Line Results From Phase 3 Study Evaluating The Efficacy And Safety Of Biosimilar Candidate ABP 501 Compared With Adalimumab

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide