An adalimumab biosimilar, adalimumab-atto (Amjevita®, Amgen), has been approved by the US Food and Drug Administration (FDA) to treat moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, active Crohn’s disease, active ulcerative colitis, and moderate to severe plaque psoriasis. These indications were previously approved indications for the adalimumab biosimilar reference product (Humira®, AbbVie).
“This is the fourth FDA-approved biosimilar,” Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, said in a press release.1 “The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.”
A biosimilar is a biological product that is approved based on showing that it is highly similar to the existing biological product, known as the RP. Differences in clinically inactive components, however, may still exist.
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted in the U.S. as part of a larger reform with the Affordable Care Act, designed to shorten the pathway to drug licensure for biological products that are shown to be “biosimilar” to an already FDA-licensed biological product.
Approval of Amjevita follows an evidence review, including animal study and human pharmacokinetic and pharmacodymanic data. Clinical immunogenicity data, clinical safety, and effectiveness data were also studied.
Serious side effects include infections and malignancies, and Amjevita contains a Boxed Warning alerting both physicians and patients of an increased risk of serious infection; lymphoma, and other malignancies have been reported in children and adolescents.
The FDA notes that Amjevita has been approved as a biosimilar, and is not an interchangeable product.
- FDA approves Amjevita, a biosimilar to Humira [press release]. Silver Spring, MD: US Food and Drug Administration. Published September 23, 2016. Accessed September 26, 2016.