FDA Approves Amjevita as a Biosimilar to Humira

The FDA has approved Amjevita, also known as adalimumab-atto, as a biosimilar to Humira. It is indicated for the treatment of multiple inflammatory diseases, such as:

· Moderately to severely active rheumatoid arthritis

· Active psoriatic arthritis

· Active ankylosing spondylitis (an arthritis that affects the spine)

· Moderately to severely active Crohn’s disease

· Moderately to severely active ulcerative colitis

· Moderate to severe plaque psoriasis

The most serious adverse effects associated with Amjevita are infections and malignancies, Injection site reactions and infections are the most common adverse effects experienced by patients. Amjevita comes with a boxed warning, similar to Humira, which warns users of an increased risk of serious infection that may cause hospitalization or death.

“This is the fourth FDA-approved biosimilar,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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 approved when it shows that it is extremely similar to an already-approved product on the market, and has no meaningful clinical differences in safety, purity, and potency.

The FDA’s approval of Amjevita is based on review of clinical data that demonstrate Amjevita is a safe and effective biosimilar to Humira. Amjevita has not been approved as an interchangeable product.

Amjevita is manufactured by Amgen, which is based in Thousand Oaks, California. Humira was originally manufactured and approved in December 2002.