Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021.

ABSTRACT: Despite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large space in the pipeline of the pharmaceutical industry and boosted the innovation portfolio and arsenal of therapeutic compounds available. Here, we report on biological drug approvals by the US Food and Drug Administration (FDA) from 2015 to 2021. The number of drugs included in this class grew over this period, totaling 90 approvals, with an average of 13 authorizations per year. This figure contrasts with previous periods, which registered between 2 and 8 approvals per year. We highlight the great potential and advantages of biological drugs. In this context, t

SUBMITTER: Martins AC 

PROVIDER: S-EPMC9496574 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature