Module 9 2024

03/09/2024

Guidance - US Food and Drug Administration (FDA)

• Guidance for Industry - Immunogenicity Assessment for Therapeutic Protein Products. Food and Drug Administration, US. August 2014. www.fda.gov/downloads/drugs/guidances/ucm338856.pdf

• Guidance for Industry – Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection. Food and Drug Administration, US. January 2019. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm603333.htm

• Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format Draft Guidance for Industry, February 2022

• Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry, March 2024

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Recommendations, AAPS White Papers & Others

Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations (2014). Shankar et al., AAPS J., 16(4): 658-73

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics (2014). Gorovits B. et al., J. Immunol. Methods., 408:1-12

Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics (2016). Wu B. et al., AAPS J., 18(6):1335-1350

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment (2017). Gouty D. et al., AAPS J., 20(1):25

Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development (2017). Xue L. et al., AAPS J., 19(6):1576-1586.

Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points (2017). Devanarayan V. et al., AAPS J., 19(5):1487-1498

Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies (2017). Zhong Z.D. et al., AAPS J., 19(6):1564-1575.

Compatibility of immunogenicity guidance by the EMA and the US FDA (2019). Kurki P., Bioanalysis 11(17):1619-1629

Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers (2019). Chamberlain P., Bioanalysis, 11(17):1581-1592.

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