The U.S. Food and Drug Administration (FDA) recently approved Amjevita, which is an almost identical copy of Humira, for multiple inflammatory diseases.

Amjevita

Amjevita has been approved for the following problems in adult patients:

Average to acutely active rheumatoid arthritis

Operational arthritis

Operational ankylosing spondylitis (a type of arthritis that affects the spine)

Average to acutely active ulcerative colitis; and

Average to acutely active plaque psoriasis

Amjevita is also used for moderately to acutely active polyarticular juvenile idiopathic arthritis in patients from age four and older.

“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, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The most severe known side-effects associated with Amjevita are infections and fatalities. Much like Humira, the labeling for Amjevita has a boxed warning to alert health care professionals and their patients to the heightened risk of serious infections, which can ultimately lead to hospitalization or death.

Health care professionals should go over the prescribed information on the labeling for details on the approved uses and information on the possible risks.

The boxed warning also indicates that lymphoma and other serious medical issues, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including Amjevita-related products.

Amjevita is manufactured by Amgen, Inc., of Thousand Oaks, California. Humira was approved in December 2002 and is manufactured by AbbVie Inc. of North Chicago, Illinois.

Sources:

“FDA approves Amjevita, a biosimilar to Humira,” U.S. Food & Drug Administration web site, Sept 23 2016; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm