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Infliximab was approved for medical use in the United States in 1998, [23] and in the European Union in August 1999. [19] Infliximab biosimilars have been approved in the EU (2013), in Japan (2014), and in the United States (2016, 2017, 2019). [1] [4] [2] It is on the World Health Organization's List of Essential Medicines. [25]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The anti-TNF-α monoclonal antibody infliximab is a major biological therapy for inflammatory bowel diseaseBiological therapy, the use of medications called biopharmaceuticals or biologics that are tailored to specifically target an immune or genetic mediator of disease, plays a major role in the treatment of inflammatory bowel disease. [1]
Drug Trade name Type Main indications Company Sales (USD millions/year) ∆ vs 2014 1 Adalimumab: Humira Biologic Rheumatoid arthritis: AbbVie Inc. 14,012 1,469 2 Ledipasvir/sofosbuvir: Harvoni Small molecule Hepatitis C: Gilead Sciences: 13,864 11,737 3 Etanercept: Enbrel Biologic Rheumatoid arthritis: Amgen. Pfizer. 8,697 4,009 4 Infliximab ...
Biocon Biologics, a unit of Biocon, said Hulio would be available at a list price of 5% below Humira's current list price. Humira comes at list price of $6,922 per carton.
The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. [9] On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz .
A TNF inhibitor is a pharmaceutical drug that suppresses the physiologic response to tumor necrosis factor (TNF), which is part of the inflammatory response.TNF is involved in autoimmune and immune-mediated disorders such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, psoriasis, hidradenitis suppurativa and refractory asthma, so TNF inhibitors may be used in their ...
The biosimilar, Yuflyma, became available for sale in the U.S. on Sunday, the company said a day later. Yuflyma is listed at $6,576.50 per month compared to the current list price of Humira at ...