Amgen Launches AMJEVITA—First Biosimilar to HUMIRA in the United States

Amgen announced today the launch of AMJEVITA (adalimumab-atto), a biosimilar to AbbVie’s HUMIRA (adalimumab), in the United States.  AMJEVITA was the first HUMIRA biosimilar approved by the FDA and is now the first to be launched in the United States. AMJEVITA is approved to treat seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis in adults, moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate-to-severe chronic plaque psoriasis in adults, moderate-to-severe Crohn’s disease in adults and pediatric patients 6 years of age and older and moderate-to-severe ulcerative colitis in adults.

According to the press release, “AMJEVITA (40 mg) is available at a list price (Wholesale Acquisition Cost) 55% below the current Humira list price. AMJEVITA is also available at a list price 5% below the current Humira list price.”

As we reported previously, Amgen and AbbVie settled their BPCIA litigation regarding AMJEVITA back in 2017. In connection with the settlement, Amgen said that AbbVie would grant patent licenses for the use and sale of AMJEVITA worldwide, with Amgen’s expected launch in the United States being today, January 31, 2023.

Amgen stated that it currently has 11 biosimilars either on the marker or under development, with five FDA-approved in the United States and three approved in the European Union.