PMID- 32340579 OWN - NLM STAT- MEDLINE DCOM- 20210811 LR - 20210811 IS - 1545-3278 (Electronic) IS - 0732-0582 (Linking) VI - 38 DP - 2020 Apr 26 TI - 30 Years of Biotherapeutics Development-What Have We Learned? PG - 249-287 LID - 10.1146/annurev-immunol-101619-031510 [doi] AB - Since the birth of biotechnology, hundreds of biotherapeutics have been developed and approved by the US Food and Drug Administration (FDA) for human use. These novel medicines not only bring significant benefit to patients but also represent precision tools to interrogate human disease biology. Accordingly, much has been learned from the successes and failures of hundreds of high-quality clinical trials. In this review, we discuss general and broadly applicable themes that have emerged from this collective experience. We base our discussion on insights gained from exploring some of the most important target classes, including interleukin-1 (IL-1), tumor necrosis factor alpha (TNF-alpha), IL-6, IL-12/23, IL-17, IL-4/13, IL-5, immunoglobulin E (IgE), integrins and B cells. We also describe current challenges and speculate about how emerging technological capabilities may enable the discovery and development of the next generation of biotherapeutics. FAU - Ghilardi, Nico AU - Ghilardi N AD - Department of Immunology, Genentech, South San Francisco, California 94080, USA; email: nico.ghilardi@gmail.com, pappu.rajita@gene.com, arron.joseph@gene.com. FAU - Pappu, Rajita AU - Pappu R AD - Department of Immunology, Genentech, South San Francisco, California 94080, USA; email: nico.ghilardi@gmail.com, pappu.rajita@gene.com, arron.joseph@gene.com. FAU - Arron, Joseph R AU - Arron JR AD - Department of Immunology, Genentech, South San Francisco, California 94080, USA; email: nico.ghilardi@gmail.com, pappu.rajita@gene.com, arron.joseph@gene.com. FAU - Chan, Andrew C AU - Chan AC AD - Research-Biology, Genentech, South San Francisco, California 94080, USA; email: acc@gene.com. LA - eng PT - Historical Article PT - Journal Article PT - Review PL - United States TA - Annu Rev Immunol JT - Annual review of immunology JID - 8309206 RN - 0 (Biological Products) SB - IM MH - Animals MH - Biological Products/history/*pharmacology/*therapeutic use MH - *Biological Therapy/history/methods MH - Biotechnology/history/methods MH - Clinical Trials as Topic MH - *Drug Development/history MH - Drug Discovery/history/methods MH - Drug Evaluation, Preclinical MH - History, 20th Century MH - History, 21st Century MH - Humans OTO - NOTNLM OT - autoimmunity OT - biotherapeutics OT - clinical trial OT - inflammation EDAT- 2020/04/29 06:00 MHDA- 2021/08/12 06:00 CRDT- 2020/04/29 06:00 PHST- 2020/04/29 06:00 [entrez] PHST- 2020/04/29 06:00 [pubmed] PHST- 2021/08/12 06:00 [medline] AID - 10.1146/annurev-immunol-101619-031510 [doi] PST - ppublish SO - Annu Rev Immunol. 2020 Apr 26;38:249-287. doi: 10.1146/annurev-immunol-101619-031510.