Antibody drugs have become an increasingly important class of therapeutics for a wide range of diseases. In this article, we will introduce the top 10 antibody drugs that have been approved by regulatory agencies from 1980 to 2022 and provide some information about their development history and the diseases they are used to treat.
Humira (adalimumab): Humira was approved by the FDA in 2002 and is used to treat rheumatoid arthritis, psoriasis, and other autoimmune disorders. It was the first fully human antibody drug approved by the FDA.
Keytruda (pembrolizumab): Keytruda was approved by the FDA in 2014 and is used to treat melanoma, lung cancer, and other cancers. It was the first PD-1 inhibitor approved by the FDA.
Herceptin (trastuzumab): Herceptin was approved by the FDA in 1998 and is used to treat HER2-positive breast cancer. It was the first monoclonal antibody drug approved for cancer treatment.
Remicade (infliximab): Remicade was approved by the FDA in 1998 and is used to treat Crohn's disease, rheumatoid arthritis, and other autoimmune disorders. It was the first anti-TNF-alpha antibody drug approved by the FDA.
Rituxan (rituximab): Rituxan was approved by the FDA in 1997 and is used to treat non-Hodgkin's lymphoma and other blood cancers. It was the first monoclonal antibody drug approved for cancer treatment.
Opdivo (nivolumab): Opdivo was approved by the FDA in 2014 and is used to treat melanoma, lung cancer, and other cancers. It was the first PD-1 inhibitor approved by the FDA.
Avastin (bevacizumab): Avastin was approved by the FDA in 2004 and is used to treat colon cancer, lung cancer, and other cancers. It was the first anti-angiogenic antibody drug approved by the FDA.
Lucentis (ranibizumab): Lucentis was approved by the FDA in 2006 and is used to treat macular degeneration, diabetic retinopathy, and other eye diseases. It was the first antibody drug approved for ophthalmic use.
Stelara (ustekinumab): Stelara was approved by the FDA in 2009 and is used to treat psoriasis, psoriatic arthritis, and Crohn's disease. It was the first interleukin inhibitor approved by the FDA.
Tecentriq (atezolizumab): Tecentriq was approved by the FDA in 2016 and is used to treat bladder cancer, lung cancer, and other cancers. It was the first PD-L1 inhibitor approved by the FDA.
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Antibody specificity refers to an antibody's ability to selectively bind to a unique epitope on a target antigen while avoiding interactions with unrelated antigens. This property arises from the highly specialized antigen-binding site located in the variable region of the antibody, which determines its unique binding characteristics.
Antibody affinity refers to the strength of the binding interaction between a single antigen epitope and the paratope (binding site) of an antibody. This interaction is a fundamental measure of how well an antibody recognizes its specific antigen target.
Recombinant antibodies are produced using genetic engineering techniques, unlike traditional antibody production, where the immune system generates antibodies without direct control over their sequence. By introducing genes encoding antibody fragments into host cells, such as bacteria or mammalian cells, recombinant antibodies can be expressed, purified, and deployed for applications including research, diagnostics, and therapeutics.
Recombinant antibody expression is a biotechnological process that involves engineering and producing antibodies outside their natural context using recombinant DNA technology.