Amgen’s Humira Biosimilar Gets FDA Green Light

In a major win for Amgen, the US Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto), a biosimilar of AbbVie’s Humira (adalimumab). As well as becoming Amgen’s first biosimilar to receive regulatory approval, Amjevita has been approved for all seven indications of the reference product, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis and moderate-to-severe ulcerative colitis.

“Approval of Amjevita is an exciting accomplishment as it marks a new chapter in Amgen’s story of being a leader in biotechnology. In addition, Amjevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” said Dr. Sean E. Harper, executive vice president of Research and Development at Amgen. “This milestone exemplifies our ongoing dedication to the development of high quality biologic medicines.”

Both Amjevita and Humira are anti-TNF-α monoclonal antibodies. Not only does Amjevita have the same amino acid sequence as the active ingredient in Humira, but it has also been deemed highly similar to the biologic.

Amgen submitted analytical, nonclinical, pharmacokinetic and clinical data to the FDA, in order to support Amjevita’s claim of biosimilarity to adalimumab. In addition, two phase III clinical trials in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis showed the drug met its primary endpoint of equivalency to Humira.

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

As a biosimilar, Amjevita is also subject to the same FDA-mandated boxed warning as Humira. The warning alerts doctors and patients to the risks associated with the drugs’ use, including increased risk of infections, hospitalization and death. In addition, a comprehensive patient medication guide must be provided along with the drug that explains the indications and risks for both the branded biologic and the biosimilar.

Amgen is still waiting for the European Medicines Agency’s (EMA) decision on Amjevita, after applying for approval in late 2015. In all, Amgen has nine ongoing projects in its biosimilar pipeline, including the newly-approved adalimumab.