Amgen Launches First Biosimilar of AbbVie’s Humira
Amgen has announced that Amjevita (adalimumab-atto), a biosimilar to AbbVie’s Humira (adalimumab), is now available in the US. Humira had 2021 sales of $20.69 billion and was AbbVie’s highest selling product.
Amjevita was approved to treat seven inflammatory diseases, including: moderate-to-severe rheumatoid arthritis in adults;, moderate-to-severe polyarticular juvenile idiopathic arthritis in patients twp 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 six years of age and older; and moderate-to-severe ulcerative colitis in adults.
Amjevita was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016. AbbVie and Amgen entered an agreement in 2017 under which AbbVie granted patent licenses for the use and sale of Amgevita/Amjevita worldwide, on a country-by-country basis, and the companies agreed to dismiss all pending litigation with an agreed-to biosimilar launch in 2023.
In addition to Amgen entered into several patent agreements with other companies for launch of a biosimilar or interchangeable product for Humira in 2023, including Boehringer Ingelheim, and Merck & Co./Samsung Bioepis.