FDA approves Humira biosimilar Amjevita from Amgen

SILVER SPRING, Md. — The Food and Drug Administration has approved Amgen’s Amjevita (adalimumab-atto), a biosimilar of AbbVie’s Amgen (adalimumab) and the fourth U.S. biosimilar, the company announced Friday. The drug — Amgen’s first biosimilar — is indicated to treat seven inflammatory conditions, among them moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and moderate to severe chronic plaque psoriasis. 

 

"Approval of Amjevita is an exciting accomplishment as it marks a new chapter in Amgen's story of being a leader in biotechnology,” Amgen’s EVP research and development Dr. Sean Harper said. “In addition, Amjevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option.”

 

Like Humira, Amjevita contains a boxed warning about increased risk of serious infections leading to hospitalization or death, the FDA said. It also notes that lymphoma and other malignancies, some of them fatal, have been reported in children and adolescent patients treated with adalimumab products. 

 

“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,” FDA Center for Drug Evaluation and Research director Dr. Janet Woodcock said.