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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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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 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 .
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.
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 ...
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]
Biosimilar is a term used to describe a biopharmaceutical product which seems so close in composition and effect to another that they are functionally identical, analogous to generic drugs. In this context, some publications describe "biologics" as "biosimilars".
csDMARDs are the traditional drugs (such as methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold salts) tsDMARDs are drugs that were developed to target a particular molecular structure; biological (bDMARD) can be further separated into original and biosimilar DMARDs (boDMARDs and bsDMARDs)