Amjevita™ (Adalimumab-atto), First Biosimilar to Humira®, Now Available in the United States

01 February 2023 | Wednesday | News


Four Years of Real-World Experience in More Than 300,000 Patients and Over 60 Countries1
Image Source : Public Domain

Image Source : Public Domain

Amgen (NASDAQ:AMGN)  announced AMJEVITA™ (adalimumab-atto), a biosimilar to Humira®* (adalimumab), is now available in the United States. AMJEVITA was the first biosimilar to Humira approved by the U.S. Food and Drug Administration (FDA), in 2016.2,3

"With today's announcement, AMJEVITA is the first U.S. biosimilar to Humira®, a medicine used by more than a million patients living with certain serious inflammatory diseases," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "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."

"Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the healthcare system," said Steven Taylor, president and chief executive officer at the Arthritis Foundation. "AMJEVITA provides another treatment option for patients and their doctors."

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. Amgen's goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers. More information on Amgen's approach to responsible pricing is on the company's website.  

Like Humira's citrate-free formulation that is associated with less pain at the injection site, AMJEVITA is citrate-free.2,4 AMJEVITA will be available in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications. Amgen offers patient support, such as financial support information and educational resources, through AMJEVITA SupportPlus. To learn more, visit AMJEVITA.com.

Amgen currently has 11 biosimilar medicines in market or under development. Five are FDA-approved in the U.S. and three are approved in the European Union.

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