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Vivian Xie
1 Feb 2023

Amgen launches first biosimilar to Humira® in US

AMJEVITA, a biosimilar to Abbvie, Inc.’s Humira®, has been launched in the US by Amgen for the treatment of several inflammatory diseases, with the goal of both providing treatments to patients and reducing healthcare costs.

California-based pharmaceutical company Amgen have announced the launch of a biosimilar to adalimumab monoclonal antibody treatment Humira®, called AMJEVITATM, in the United States. It was the first biosimilar to Humira to be approved by the US FDA in 2016.

As a biosimilar to Humira, AMJEVITA operates as an anti-TNF-α monoclonal antibody. The active ingredient maintains the same amino acid sequence as Humira, and is approved for the therapeutic use against seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, among others. Executive VP of Global Commercial Operation at Amgen Murdo Gordon commented: “...AMJEVITA is the first US biosimilar to Humira, a medicine used by more than a million patients living with certain serious inflammatory diseases... With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply this biosimilar medicine while reducing costs.” 

AMJEVITA (40 mg) is available in the United States at a listing price 55% below the Humira list price. Its formulation, similar to Humira, involves a citrate-free formulation associated with less pain at the injection site. The formulation will be available in prefilled syringes and autoinjectors to support the dosing of AMJEVITA for approved indications. Amgen currently has 11 biosimilar medicines in development, with five approved in the US by the US FDA and three approved in the EU. 

Steven Taylor, President and CEO of the Arthritis Foundation, stated: “Biosimilar are extensively studied, FDA-approved treatments that have the potential to reduce costs to the healthcare system... AMJEVITA provides another treatment option for patients and their doctors.” 


Vivian Xie
Editor - Custom Content