This document provides information on therapeutic antibody drugs that have been approved by the FDA. Over 60 antibody drugs have been approved for treating various diseases like cancer, immune disorders, and infections. In 2016, worldwide revenues from antibody drugs reached almost $89 billion. There are currently 550 antibodies in clinical development. Soon after monoclonal antibodies were first described in 1975, they became valuable research tools for diagnosis and investigation. New technologies now allow for fully human antibodies to be isolated. The development of therapeutic antibodies is described in detail to help scientists understand this area of research.

1. CREATIVE BIOLABS • RECOMBINANT ANTIBODY
45-1 Ramsey Road, Shirley, NY 11967, USA
Email: info@creative-biolabs.com 1 / 20
In this review, we collected the date and related information of therapeutic antibody drugs
approved by FDA to form a comprehensive list including therapeutic antibodies name (INN and
trade name), sourced companies, target, MoA, and first approval year, etc. Meanwhile, classification
and naming of therapeutic antibody are also described in detail. Combing a brief introduction of
MoA of therapeutic antibody, corresponding antibody-based therapy strategy is summarized and
will assist researchers to comprehend therapeutic antibody for boosting their valuable studies.
Approved Therapeutic Antibody Drug and Revenue
Antibody-based therapeutics currently enjoy unprecedented success, growth in research and
revenues, and recognition of their potential. It appears that the promise of the ‘‘magic bullet’’ has
been well recognized. Over 60 antibody-based drugs have been approved by the United States Food
and Drug Administration (FDA) for therapeutic use. 550 antibodies are in clinical development for
treatment of various diseases, including oncology, immune disorders, inflammatory diseases,
transplantation and infections. The worldwide revenues of them reached almost $89 billion in 2016
(Table. 1). In the first half of 2017, antibody drug market capacity has reached US$49 billion and it
is estimated that it will exceed $100 billion for the first time in 2017.
Soon after the first description of monoclonal antibodies (mAbs) in 1975(a discovery that led to a
Nobel Prize 10 years later), mAbs were recognized as unique biological tools and quickly became
invaluable in pathological diagnosis and basic laboratory investigation. With the development of
some new technologies, such as phage display, humanized transgenic mice, and repertoire mining, fully
human antibodies can be isolated. The development history of therapeutic antibody is described in detail
by Creative Biolabs for scientists and customers who are interested in it. The natural complexity of the
antibody molecules and the rapid implementation of engineering methodologies helped in making them
ideal candidates for new applications and for the solution of complex immunotherapeutic challenges.