Abstract
Objective: To study the trends in the approval of biopharmaceuticals focusing on the 30-years history of Division of Biological Chemistry and Biologicals, National Institute of Health Sciences (NIHS).
Methods: Approval information was obtained from the website of the Division of Biological Chemistry and Biologicals and the database of the Pharmaceuticals and Medical Devices Agency (PMDA).
Results and Discussion: Stage 1 (1989-1998) Seventeen biopharmaceuticals including five hormones, three enzymes, three cytokines, and two human erythropoietins (r-hEPO) were approved and have been used to date. Stage 2 (1999-2008) Thirty-four biopharmaceuticals including 12 antibodies, seven hormones, six enzymes, and three interferons were approved and have been used to date. Stage 3 (2009-2018) Eighty-two biopharmaceuticals including 43 antibodies, 13 factors of blood coagulation and fibrinolysis, nine hormones, eight enzymes, four fusion proteins, and three vaccines were approved and have been used to date. The number of biopharmaceuticals were not counted in the case of expiration.
