ResourcesBlogTop 10 Antibody Drug Approvals from FDA 1980-2022
Top 10 Antibody Drug Approvals from FDA 1980-2022
Biointron2023-12-18Read time: 4 mins
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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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Antibodies are versatile molecules that perform a range of effector functions, many of which engage different arms of the immune system. Their modes of action extend beyond simple antigen binding, enabling the activation of various immune mechanisms that lead to pathogen neutralization and clearance. These functions include blocking molecular interactions, activating the complement system, and linking the humoral immune response to cellular immune responses via Fc receptor engagement.
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In addition to isotypes and subtypes, antibodies exhibit genetic variation known as allotypes, which are polymorphic epitopes on immunoglobulins. These allotypic differences arise from allelic variations in immunoglobulin genes, causing certain antibody subtypes to differ between individuals or ethnic groups. The presence of these polymorphic forms can influence immune responses, particularly when an individual is exposed to a non-self allotype, potentially triggering an anti-allotype immune reaction.
In mammals, antibodies are classified into five major isotypes: IgA, IgD, IgE, IgG, and IgM. Each isotype is defined by the heavy chain it contains: alpha (IgA), delta (IgD), epsilon (IgE), gamma (IgG), or mu (IgM). These structural differences in the heavy chains determine the antibody's function, tissue localization, and role in the immune response. Furthermore, antibody light chains fall into two classes—kappa and lambda—with kappa being more common, though both exhibit similar functions despite differences in sequence.
