GuidanceHome Scientific Expertise Scientific Insights Guidance Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar ProgramsPDF (302.43 KB)Download Find Out More Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019PDF (371.72 KB)Download Find Out More FDA Guidance for Industry: Bioanalytical Method Validation, May 2018PDF (362.06 KB)Download Find Out More Guidance for Industry (Draft Guidance): Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016PDF (230.21 KB)Download Find Out More EMA Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins, September 2015PDF (413.36 KB)Download Find Out More Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product, April 2015PDF (144.19 KB)Download Find Out More Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, April 2015PDF (169.02 KB)Download Find Out More EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, December 2014PDF (164.72 KB)Download Find Out More FDA Guidance for Industry: Immuogenicity Assessment for Therapeutic Protein Products, February 2013PDF (208.58 KB)Download Find Out More EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, November 2012PDF (104.00 KB)Download Find Out More 1 2 3 Next
