Authors
Caroline Mignard, Didier Grillot, Nicolas Ancellin, Sylvie Maubant, Olivier Duchamp, Fabrice Viviani
Introduction
New biological entities or biological therapeutic products (namely Biologics) include a huge diversity of products such as vaccines, gene and cellular therapies, recombinant therapeutic proteins, naked or conjugated monoclonal antibodies, bispecific antibody-like structure and others. Biologics can be composed of sugars, proteins, nucleic acids or complex combinations of these substances, or may even be living entities.
Biologics made a first revolution in cancer treatment with approval of rituximab and trastuzumab in late 1990’s (two monoclonal antibodies targeting antigens expressed on tumor cells). A second major revolution was brought in the early 2010’s with the approval of antibodies that target immune checkpoint on immune cells (i.e. ipilimumab targeting CTLA-4 positive regulatory CD4 T cells and nivolumab or pembrolizumab, both targeting PD-1 on T cells) rather than tumor cells.
Since 2017, there have been about 10 to 15 biologics approved each year, and many much more in clinical development, which represents a rapidly growing market in various therapeutic areas such as oncology, autoimmune diseases, inflammation, infectious diseases and others.