The active ingredient of AMJEVITA is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as Humira. 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. and three are approved in the European Union.ĪMJEVITA is a biosimilar to Humira ®* (adalimumab), an anti-TNF-α monoclonal antibody. To learn more, visit .Īmgen currently has 11 biosimilar medicines in market or under development. Amgen offers patient support, such as financial support information and educational resources, through AMJEVITA SupportPlus. 2,4 AMJEVITA will be available in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications. Like Humira's citrate-free formulation that is associated with less pain at the injection site, AMJEVITA is citrate-free. More information on Amgen's approach to responsible pricing is on the company's website. Amgen's goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers. AMJEVITA is also available at a list price 5% below the current Humira list price. "AMJEVITA provides another treatment option for patients and their doctors."ĪMJEVITA (40 mg) is available at a list price (Wholesale Acquisition Cost) 55% below the current Humira list price. "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. "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." 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 today's announcement, AMJEVITA is the first U.S. Food and Drug Administration (FDA), in 2016. AMJEVITA was the first biosimilar to Humira approved by the U.S. 31, 2023 /PRNewswire/ - Amgen (NASDAQ:AMGN) today announced AMJEVITA™ (adalimumab-atto), a biosimilar to Humira ®* (adalimumab), is now available in the United States. Clinical Trial Diversity and RepresentationĬlinical Trial Transparency, Data Sharing and Disclosure PracticesĪdverse Event and Product Complaint ReportingĮnvironmental, Social & Governance Report 2022Įnvironment, Social and Governance StrategyĬommunity Investment and Amgen Foundationįour Years of Real-World Experience in More Than 300,000 Patients and Over 60 Countries 1
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