Adalimumab-atto, Fourth Biosimilar Approved by the FDA

Online First - FDA Approvals

On September 23, 2016, the US Food and Drug Administration (FDA) approved adalimumab-atto (Amjevita; Amgen) as a biosimilar to adalimumab (Humira; AbbVie) for the treatment of several indications and inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; moderate-to-severe Crohn’s disease; moderate-to-severe ulcerative colitis; and moderate-to-severe plaque psoriasis.

The new biosimilar is also indicated for the treatment of moderate-to-severe polyarticular juvenile idiopathic arthritis in patients aged ≥4 years.

“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research.

As in the case of the previous 3 biosimilars, adalimumab-atto is approved as a biosimilar, not as an interchangeable agent.

The approval of adalimumab-atto is based on review of evidence from human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other data demonstrating the clinical safety and effectiveness of this drug, showing that adalimumab-atto is indeed biosimilar to adalimumab.

The most common expected adverse events with adalimumab-atto are infections and injection-site reactions. This biosimilar carries a boxed warning about an increased risk for serious infections, as well as a warning that lymphoma and other malignancies have been reported in children and adolescent patients who received this type of drug.  

The third biosimilar, etanercept-szzs (Erelzi; Sandoz), was approved by the FDA on August 30, 2016, as a biosimilar to etanercept (Enbrel; Novartis) for the same indications as those approved for the reference drug.

The second biosimilar to receive FDA approval was infliximab-dyyb (Inflectra; Celltrio), a biosimilar to infliximab (Remicade; Janssen). Infliximab-dyyb was approved on April 5, 2016, for the same indications as its reference drug.

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Last modified: October 17, 2016
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