Sauna ZE, Lagassé D, Pedras-Vasconcelos J, Golding B, Rosenberg AS. Evaluating and mitigating the immunogenicity of therapeutic proteins. Trends Biotechnol. 2018;36:1068–84. https://doi.org/10.1016/j.tibtech.2018.05.008.

Article  CAS  PubMed  Google Scholar 

Smith A, Manoli H, Jaw S, Frutoz K, Epstein AL, Khawli LA, et al. Unraveling the effect of immunogenicity on the PK/PD, efficacy, and safety of therapeutic proteins. J Immunol Res. 2016;2016:2342187. https://doi.org/10.1155/2016/2342187.

Article  CAS  PubMed  PubMed Central  Google Scholar 

US Food and Drug Administration. Immunogenicity information in human prescription therapeutic protein and select drug product labeling—content and format: guidance for industry. Published February 2022. https://www.fda.gov/media/155871/download. Accessed 31 May 2025.

US Food and Drug Administration. Immunogenicity assessment for therapeutic protein products: guidance for industry. Published August 2014. https://www.fda.gov/media/85017/download. Accessed 31 May 2025.

European Medicines Agency. Guideline on immunogenicity assessment of therapeutic proteins. Committee for Medicinal Products for Human Use (CHMP). Published 18 May 2017. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf. Accessed 31 May 2025.

International Council for Harmonisation. M4E(R2): efficacy – revision of M4E guideline on enhancing the format and structure of benefit-risk information in ICH. ICH harmonised guideline. Published 15 June 2016. https://database.ich.org/sites/default/files/M4E_R2__Guideline.pdf. Accessed 31 May 2025.

Wang YMC, Wang J, Hon YY, Zhou L, Fang L, Ahn HY. Evaluating and reporting the immunogenicity impacts for biological products—a clinical pharmacology perspective. AAPS J. 2016;18:395–403. https://doi.org/10.1208/s12248-015-9857-y.

Article  CAS  PubMed  Google Scholar 

Richards S, Winzenborg I, Luedtke D, Niu T, Hamuro L, Kowalski K, et al. IQ survey results on current industry practices: Part 2—quantitative evaluations of immunogenicity assessment. Clin Pharmacol Ther. 2025;117:123–31. https://doi.org/10.1002/cpt.3573.

Ishibai M, Kai M, Wakuda H, Oikawa I, Uemura N. Assessing immunogenicity in drug reviews and prescribing information in Japan. AAPS J. 2024;26:109. https://doi.org/10.1208/s12248-024-00980-0.

Article  PubMed  Google Scholar 

Kothari M, Wanjari A, Acharya S, Karwa V, Chavhan R, Kumar S, et al. A comprehensive review of monoclonal antibodies in modern medicine: tracing the evolution of a revolutionary therapeutic approach. Cureus. 2024;16:e61983. https://doi.org/10.7759/cureus.61983.

Article  PubMed  PubMed Central  Google Scholar 

Mekala JR, Nalluri HP, Reddy PN, Sainath SB, Sampath Kumar NS, Sai Kiran GVSD, et al. Emerging trends and therapeutic applications of monoclonal antibodies. Gene. 2024;925:148607. https://doi.org/10.1016/j.gene.2024.148607.

Article  CAS  PubMed  Google Scholar 

de la Torre BG, Albericio F. The pharmaceutical industry in 2024: an analysis of the FDA drug approvals from the perspective of molecules. Molecules. 2025;30:482. https://doi.org/10.3390/molecules30030482.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Asmani AZA, Zainuddin AFF, Murad NAA, Darwis NHM, Suhaimi NS, Zaini E, et al. Immunogenicity of monoclonal antibody: causes, consequences, and control strategies. Pathol Res Pract. 2024;247:155627. https://doi.org/10.1016/j.prp.2024.155627.

Article  CAS  Google Scholar 

Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Guidelines for Prescribing Information of Medical Drugs [in Japanese]. Published 8 June 2017. https://www.pmda.go.jp/files/000218446.pdf. Accessed 31 May 2025.

World Health Organization. New INN monoclonal antibody (mAb) nomenclature scheme. Published November 2021. https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/new_mab_-nomenclature-_2021.pdf. Accessed 31 May 2025.

Miller FW. The increasing prevalence of autoimmunity and autoimmune diseases: an urgent call to action for improved understanding, diagnosis, treatment, and prevention. Curr Opin Immunol. 2022;80:102266. https://doi.org/10.1016/j.coi.2022.102266.

Article  CAS  PubMed  PubMed Central  Google Scholar 

National Academies of Sciences, Engineering, and Medicine. Enhancing NIH Research on Autoimmune Disease. Washington, DC: National Academies Press; Published 2022. https://nap.nationalacademies.org/catalog/26554/enhancing-nih-research-on-autoimmune-disease. Accessed August 30, 2025.

Fendler A, de Vries EGE, GeurtsvanKessel CH, Haanen JB, Wörmann B, Turajlic S, et al. COVID-19 vaccines in patients with cancer: immunogenicity, efficacy and safety. Nat Rev Clin Oncol. 2022;19:385–401. https://doi.org/10.1038/s41571-022-00610-8.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Teeyapun N, Wanchaijiraboon P, Pakvisal N, Sainamthip P, Susiriwatananont T, Zungsontiporn N, et al. Immunogenicity of ChAdOx1-nCoV-19 vaccine in solid malignancy patients by treatment regimen versus healthy controls: a prospective, multicenter observational study. EClinicalMedicine. 2022;52:101608. https://doi.org/10.1016/j.eclinm.2022.101608.

Article  PubMed  PubMed Central  Google Scholar 

Malard F, Gaugler B, Gozlan J, Bouquet L, Fofana D, Siblany L, et al. Weak immunogenicity of SARS-CoV-2 vaccine in patients with hematologic malignancies. Blood Cancer J. 2021;11:142. https://doi.org/10.1038/s41408-021-00534-z.

Article  PubMed  PubMed Central  Google Scholar 

Zettler ME. Dose optimization of targeted therapies for oncologic indications. Cancers (Basel). 2024;16:2180. https://doi.org/10.3390/cancers16122180.

Article  CAS  PubMed  Google Scholar 

U.S. Food and Drug Administration. Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases: Guidance for Industry. Published August 2024. https://www.fda.gov/media/164555/download. Accessed 6 June 2025.

Doevendans E, Schellekens H. Immunogenicity of innovative and biosimilar monoclonal antibodies. Antibodies (Basel). 2019;8:21. https://doi.org/10.3390/antib8010021.

Article  CAS  PubMed  Google Scholar 

Hwang WYK, Foote J. Immunogenicity of engineered antibodies. Methods. 2005;36:3–10. https://doi.org/10.1016/j.ymeth.2005.01.001.

Article  CAS  PubMed  Google Scholar 

Atiqi S, Hooijberg F, Loeff FC, Rispens T, Wolbink GJ. Immunogenicity of TNF-inhibitors. Front Immunol. 2020;11:312. https://doi.org/10.3389/fimmu.2020.00312.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Grimaldi C, Richards S, Baltrukonis D, Belouski SS, Coble K, Dholakiya SL, et al. IQ survey results on current industry practices—Part 1: immunogenicity risk assessment. Clin Pharmacol Ther. 2025;117:1596–604. https://doi.org/10.1002/cpt.3568.

Article  PubMed  PubMed Central  Google Scholar 

Shakhnovich V, Meibohm B, Rosenberg AS, Kierzek AM, Hasenkamp R, Funk RS, et al. Immunogenicity in clinical practice and drug development: when is it significant? Clin Transl Sci. 2020;13:219–23. https://doi.org/10.1111/cts.12717.

Article  PubMed  Google Scholar 

Chirmule N, Jawa V, Meibohm B. Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy. AAPS J. 2012;14:296–302. https://doi.org/10.1208/s12248-012-9340-y.

Article  CAS  PubMed  PubMed Central  Google Scholar