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Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs
Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019
FDA Guidance for Industry: Bioanalytical Method Validation, May 2018
Guidance for Industry (Draft Guidance): Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016
EMA Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins, September 2015
Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product, April 2015
Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, April 2015
EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, December 2014
FDA Guidance for Industry: Immuogenicity Assessment for Therapeutic Protein Products, February 2013
EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, November 2012
FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, February 2012
EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, EMA/INS/GCP/532137/2010, February 2012
EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010
EMA Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, June 2009
EMA Concept paper/recommendation on the need for a (CHMP) guideline onthe validation of bioanalytical methods, March 2009
EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, December 2007
EMA Guideline on non-clinical and clinical development of similar biological medicinal products containing recominant EPOs, October 2005
EMA ICH Topic E 6 (R1) Guideline for Good Clinical Practice, CPMP/ICH/135/95, July 2002
FDA Guideline on validation of bioanalytical methods, May 2001
ICH Q2B Guideline Validation of Analytical Procedures Methodology
ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals