FDA approves drug biosimilar to Humira

The U.S. Food and Drug Administration (FDA) approved a new drug called Amjevita Sept. 23. The drug, adalimumab-atto, from Amgen, a pharmeceutical company in Thousand Oaks, California, is biosimilar to the AbbVie drug Humira (adalimumab).

The new drug is approved for treatment of inflammatory diseases, according to an FDA statement, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis and polyarticular juvenile diopathic arthritis.

The FDA warned that the biosimilar product is not “interchangeable” with Humira—it has its own potential side effects such as infections and injection site reactions. The drug does have a Boxed Warning, like Humira, to warn prescribers against the potential for serious infections and other even more dangerous issues in children and adolescents.

According to the FDA statement, Amjevita won its approval by proving there were no significant differences in safety and efficacy between it and Humira.

FDA Center for Drug Evaluation and Research Director Janet Woodcock, MD, called the biosimilar approval path a “new frontier” that could hold answers to treatment for sick patients.