1. National Cancer Institute at the National Institute of Health. Definition of biotherapy. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/biotherapy. Accessed 17 Feb 2023.
2. United States Food and Drug Administration. Center for Drug Evaluation and Research. 21 CFR 600. 2020–03505. Definition of the term biological product. 2020;85(35):10057–63. https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product. Accessed 17 Feb 2023.
3. Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides – harmonized terminology and tactical recommendations. AAPS J. 2014;16(4):658–73. https://doi.org/10.1208/s12248-014-9599-2.
4. Hamuro L, Kijanka G, Kinderman F, Kropshofer H, Bu DX, Zepeda M, et al. Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins. J Pharm Sci. 2017;106(10):2946–54. https://doi.org/10.1016/j.xphs.2017.05.030.
5. United States Food and Drug Administration, Center for Drug Evaluation and Research. Guidance document: Immunogenicity assessment for therapeutic protein products. 2014. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immunogenicity-assessment-therapeutic-protein-products. Accessed 17 Feb 2023.