Table 1.
FDA biologics approvals in 2020
| Drug name | Generic name | Indication | Molecule type |
|---|---|---|---|
| Blenrepa | Belantamab mafodotin-blmf | Multiple myeloma | Humanized anti-BCMA IgG1 mAb conjugated to auristatin F via a non-cleavable linker |
| Danyelzaa | Naxitamab-gqgk | Neuroendocrine tumors | Humanized IgG3 3F8 mAb targeting ganglioside GD2 and cluster of differentiation 3 |
| Darzalex Faspro | Daratumumab/hyaluronidase-fihj | Multiple myeloma | Fully human IgG1 anti-CD38 mAb |
| Ebanga | Ansuvimab-zykl | Ebola virus infection | Fully human IgG1 mAb isolated from a survivor of the 1995 outbreak. |
| Enspryng | Satralizumab-mwge | Neuromyelitis optica (Devic’s syndrome) | Humanized IgG2 anti-interleukin-6 receptor mAb |
| Imcivree | Setmelanotide | Metabolic syndrome | Small peptide agonist with specificity for melanocortin-4 receptor |
| Inmazeb | Atoltivimab/maftivimab/odesivimab-ebgn | Ebola virus infection | Cocktail of three human IgG1 mAbs directed against three Ebola epitopes |
| Margenza | Margetuximab-cmkb | Breast cancer | Fc optimized chimeric IgG1 anti-epidermal growth factor receptor (EGFR) mAb |
| Monjuvia | Tafasitamab-cxix | Diffuse large B-cell lymphoma | Fc optimized humanized IgG1 anti-CD19 mAb |
| Phesgo | Trastuzumab/pertuzumab | Breast cancer | Fixed dose combination of Herceptin and Perjeta (pertuzumab), two anti-EGFR humanized IgG1 mAbs |
| Sarclisa | Isatuximab-irfc | Multiple myeloma | Humanized IgG1 mAb against CD38 |
| Sogroya | Somapacitan-beco | Short stature | Recombinant human growth hormone analog with a single substitution in the backbone (L101C) to which an albumin is attached via a hydrophilic spacer |
| Tecartusa | Brexucabtagene autoleucel | Mantle cell lymphoma | CD19-directed genetically modified autologous CAR-T cell |
| Tepezza | Teprotumumab-trbw | Thyroid eye disease | IgG1 mAb that targets insulin-like growth factor 1 receptor |
| Trodelvya | Sacituzumab govitecan-hziy | Breast cancer | Humanized IgG1κ monoclonal mAb conjugated with SN-38, a topoisomerase inhibitor, using hydrolysable linker CL2A |
| Uplizna | Inebilizumab-cdon | Neuromyelitis optica | Humanized IgG4 anti-CD19 mAb |
| Vyepti | Eptinezumab-jjmr | Migraine and other headaches | Humanized IgG1 anti-CGRP mAb |
| Notable new molecular entities | |||
| Oxlumo | Lumasiran | Hyperoxaluria | siRNA oligonucleotide |
| Viltepso | Viltolarsen | Duchenne muscular dystrophy | Phosphorodiamidate morpholino ASO |
aAccelerated approval.
mAb, monoclonal antibody; ASO, antisense oligonucleotide.