First Adalimumab Biosimilar Launches in US Market


Adalimumab-atto was first approved by the FDA in 2016.

Adalimumab-atto (Amjevita), the first FDA approved adalimumab (Humira) biosimilar, is now available in the United States, according to a press release from manufacturer Amgen.1

According to the 2016 FDA approval announcement, adalimumab-atto is approved to treat moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, and moderate to severe plaque psoriasis in adults.2 The medication is also approved for treatment of moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients aged 4 years and older.2

At the time of its approval, adalimumab-atto was the fourth biosimilar medication approved by the FDA. The approval was based on an evidence review including the structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.

Adalimumab-atto 40 mg is available at 2 prices: $3288 and $1557 for a 2-week supply of medication—a discount of 5% and 55%, respectively, compared with adalimumab.1,3 According to Amgen, the company’s goal “is to provide broad access for patients by offering 2 options to health plans and pharmacy benefit managers.”1

“Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the health care system,” said Steven Taylor, president and CEO at the Arthritis Foundation. “[Adalimumab-atto] provides another treatment option for patients and their doctors.”1

Several other adalimumab biosimilars are set to launch in the United States in July.3


1. Amjevita (adalimumab-atto), first biosimilar to humira, now available in the United States. News release. Amgen. January 31, 2023. Accessed January 31, 2023.

2. FDA approves Amjevita, a biosimilar to Humira. News release. FDA. September 23, 2016. Accessed January 31, 2023.

3. Mandowara K. Amgen launches biosimilar version of AbbVie’s Humira. Reuters. Published January 31, 2023. Accessed January 31, 2023.

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