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Guidance for Industry (Draft Guidance): Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016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