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Amjevita Approval History

FDA Approved: Yes (First approved September 23, 2016)
Brand name: Amjevita
Generic name: adalimumab-atto
Dosage form: Injection
Previous Name: ABP 501
Company: Amgen Inc.
Treatment for: Plaque Psoriasis, Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohn's Disease, Maintenance, Psoriatic Arthritis, Juvenile Idiopathic Arthritis

Amjevita (adalimumab-atto) an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, juvenile idiopathic 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

Further information

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