Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs

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Guidance for Industry (Draft Guidance): Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016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