2015: An extraordinary year for first marketing approvals of antibody therapeutics

The number of novel antibody therapeutics that received a first marketing approval in 2015 exceeded expectations, with 8 (alirocumab (Praluent®), elotuzumab (Empliciti®), evolocumab (Repatha®), daratumumab (Darzalex®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®), necitumumab (Portrazza)) granted their first approval as of late December. A total of 9 antibody therapeutics were granted a first US approval in 2015, including all 8 antibodies noted above as well as secukinumab (Cosentyx®), which received a first approval in Japan in 2014. In the European Union, the European Commission also granted marketing approvals to 9 antibody therapeutics in 2015, including 5 antibodies noted above ((alirocumab (Praluent®), evolocumab (Repatha®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®)) and 4 products that had been previously approved in another country. A table of therapeutic monoclonal antibodies approved or in review in the European Union or the United States can be found in the Members Only section of The Antibody Society’s website.