Table 1.
Overview of FDA approved fully human or humanized mAbs and their reported ADA rates
| mAb | Target | Isotype | Type | ADA (range) (%) | USA approval |
|---|---|---|---|---|---|
| Adalimumab | TNF-α | IgG1 | Human | 3–61 | 2002 |
| Aducanumab | amyloid-β | IgG1 | Human | 0.6 | 2021 |
| Alemtuzumab | CD52 | IgG1 | Humanized | 29–83 | 2001 |
| Alirocumab | PCSK9 | IgG1 | Human | 5.5 | 2015 |
| Anifrolumab | IFNAR1 | IgG1 | Human | 1.7 | 2021 |
| Atezolizumab | PD-L1 | IgG1 | Humanized | 13–48 | 2016 |
| Avelumab | PD-L1 | IgG1 | Human | 8.5–19.1 | 2017 |
| Belimumab | BLyS | IgG1 | Humanized | 0.6–4.8 | 2011 |
| Benralizumab | IL-5R | IgG1 | Human | 13 | 2017 |
| Bevacizumab | VEGF-A | IgG1 | Humanized | 0.2–0.6 | 2004 |
| Bezlotoxumab | C. difficile toxin B | IgG1 | Human | 0 | 2016 |
| Bimekizumab | IL-17A,IL-17F | IgG1 | Humanized | 31–45 | 2023 |
| Brodalumab | IL17RA | IgG2 | Human | 3 | 2017 |
| Brolucizumab | VEGF-A | scFv | Human | 53–76 | 2019 |
| Burosumab | FGF23 | IgG1 | Human | 0–19 | 2018 |
| Canakinumab | IL-1β | IgG1 | Human | 1.5–3.1 | 2009 |
| Cemiplimab | PD-1 | IgG4 | Human | 2.2 | 2018 |
| Certolizumab | TNF-α | IgG1 | Humanized | 8–28 | 2008 |
| Crizanlizumab | P-selectin | IgG2 | Humanized | 0–1.6 | 2019 |
| Daclizumab | CD25 | IgG1 | Humanized | 12–19 | 2016 |
| Daratumumab | CD38 | IgG1 | Human | 0 | 2015 |
| Denosumab | RANKL | IgG2 | Human | 0.67 | 2010 |
| Dostarlimab | PD-1 | IgG4 | Humanized | 2.5 | 2021 |
| Dupilumab | IL‐4Rα | IgG4 | Human | 1–16 | 2017 |
| Durvalumab | PD-L1 | IgG1 | Human | 0.8–3 | 2017 |
| Eculizumab | C5 | IgG2/4 | Humanized | 0–3 | 2007 |
| Efalizumab | CD11a | IgG1 | Humanized | 6.3 | 2003 |
| Elotuzumab | SLAMF7 | IgG1 | Humanized | 18.5–36 | 2015 |
| Epcoritamab | CD20, CD3 | IgG1 | Humanized | 2.6 | 2023 |
| Emapalumab | IFNG | IgG1 | Human | 3–5 | 2018 |
| Eptinezumab | CGRP | IgG1 | Humanized | 18–20.6 | 2020 |
| Erenumab | CGRPR | IgG2 | Human | 2.6–6.2 | 2018 |
| Evinacumab | ANGPTL3 | IgG4 | Human | 0 | 2021 |
| Evolocumab | PCSK9 | IgG2 | Human | 0.3 | 2015 |
| Faricimab | VEGF-A/Ang-2 | IgG1 | Humanized | 8.4–10.4 | 2022 |
| Fremanezumab | CGRP | IgG2a | Human | 0.4–1.6 | 2018 |
| Galcanezumab | CGRP | IgG4 | Human | 4.8–12.5 | 2018 |
| Glofitamab | CD20, CD3e | IgG1 | Humanized | 1.1 | 2023 |
| Golimumab | TNFα | IgG1 | Human | 19–31 | 2009 |
| Guselkumab | IL-23 | IgG1 | Human | 2–9 | 2017 |
| Ibalizumab | CD4 | IgG4 | Humanized | 0.6 | 2018 |
| Idarucizumab | dabigatran | Fab | Humanized | 2–4 | 2015 |
| Ipilimumab | CTLA-4 | IgG1 | Human | 1.1–36.7 | 2011 |
| Ixekizumab | IL-17A | IgG4 | Humanized | 5.2–22 | 2016 |
| Lanadelumab | pKal | IgG1 | Human | 5–12 | 2018 |
| Lecanemab | Aβ | IgG1 | Humanized | 40.9 | 2023 |
| Loncastuximab tesirine | CD19 | IgG1 | Humanized | 0 | 2021 |
| Mepolizumab | IL-5 | IgG1 | Humanized | < 2–6 | 2015 |
| Mosunetuzumab | CD20, CD3 | IgG1 | Humanized | 0 | 2022 |
| Mogamulizumab | CCR4 | IgG1 | Humanized | 14.1 | 2018 |
| Natalizumab | α4-integrin | IgG4 | Humanized | 9–10 | 2004 |
| Naxitamab | GD2 | IgG1 | Humanized | 8–23 | 2020 |
| Necitumumab | EGFR | IgG1 | Human | 4.1 | 2015 |
| Nivolumab | PD-1 | IgG4 | Human | 11 | 2014 |
| Obinutuzumab | CD20 | IgG1 | Humanized | 0.27 | 2013 |
| Ocrelizumab | CD20 | IgG1 | Humanized | ~ 1 | 2017 |
| Ofatumumab | CD20 | IgG1 | Human | < 1 | 2009 |
| Olaratumab | PDGFRα | IgG1 | Human | 3.5 | 2016 |
| Omalizumab | IgE | IgG1 | Humanized | < 0.1 | 2003 |
| Palivizumab | RSV F protein | IgG1 | Humanized | 1.1–1.5 | 1998 |
| Panitumumab | EGFR | IgG2 | Human | 0.5–5.3 | 2006 |
| Pembrolizumab | PD-1 | IgG4 | Humanized | 2.1 | 2014 |
| Pertuzumab | HER2 | IgG1 | Humanized | 0.3–3 | 2012 |
| Polatuzumab vedotin | CD79b | IgG1 | Humanized | 1.4–6 | 2019 |
| Ramucirumab | VEGFR2 | IgG1 | Human | 3 | 2014 |
| Ranibizumab | VEGF-A | IgG1 | Humanized | 1–9 | 2022 |
| Ravulizumab | C5 | IgG2/4 | Humanized | 0.5–1.4 | 2018 |
| Reslizumab | IL-5 | IgG4 | Humanized | 4.8–5.4 | 2016 |
| Relatlimab and Nivolumab | LAG-3 | IgG4 | Human | 3.8–5.6 | 2022 |
| Retifanlimab | PD-1 | IgG4 | Humanized | 2.9 | 2023 |
| Risankizumab | IL-23 | IgG1 | Humanized | 12.1–24 | 2019 |
| Romosozumab | sclerostin | IgG2 | Humanized | 18.1 | 2019 |
| Rozanolixizumab | FcRn | IgG4 | Humanized | 37 | 2023 |
| Sarilumab | IL-6R | IgG1 | Human | 9.2 | 2017 |
| Satralizumab | IL-6R | IgG2 | Humanized | 38–73 | 2020 |
| Secukinumab | IL-17A | IgG1 | Human | < 1 | 2015 |
| Spesolimab | IL-36R | IgG1 | Humanized | 46 | 2022 |
| Sutimlimab | C1s | IgG4 | Humanized | 0 | 2022 |
| Teclistamab | BCMA, CD3 | IgG4 | Humanized | 0.5 | 2022 |
| Teplizumab | CD3 | IgG1 | Humanized | 57 | 2022 |
| Teprotumumab | IGF-1R | IgG1 | Human | 0 | 2020 |
| Tezepelumab | TSLP | IgG2 | Human | 5 | 2021 |
| Tildrakizumab | IL-23 | IgG1 | Humanized | 6.5 | 2018 |
| Tocilizumab | IL-6R | IgG2 | Humanized | 2 | 2010 |
| Tralokinumab | IL-13 | IgG4 | Human | 1.4–4.6 | 2021 |
| Trastuzumab | HER2 | IgG1 | Humanized | 10 | 1998 |
| Tremelimumab | CTLA-4 | IgG2a | Human | 11 | 2022 |
| Ustekinumab | IL-12, IL-23 | IgG1 | Human | 6–12.4 | 2009 |
| Vedolizumab | α4β7 integrin | IgG1 | Humanized | 4–13 | 2014 |