生物药物免疫原性评价FDA意见综述.ppt

生物药物免疫原性评价FDA意见综述
Disclaimer
Views expressed in this presentation are personal, and reflective of my experience as an immunogenicity reviewer for the Office of Biotechnology Products.
My views are not necessarily reflective of views or current policies of the FDA.
The “Integrated Summary of Immunogenicity” is optional for BLAs
FDA may include an ISI recommendation in new version of 2016 guidance
Immunogenicity at the FDA
Who reviews it?
Depends on the class of product
CDER - monoclonal antibodies, growth factors, fusion proteins, cytokines, enzymes, therapeutic toxins
CBER- allergenics, blood and blood components including clotting factors, cellular and gene therapies, vaccines
Office of Biotechnology Products (OBP)
CMC for 351 (a) and 351 (k) biologics under CDER purview
Currently 4 product divisions with mixed portfolios
Collaborate in immunogenicity risk assessments and review validation of clinical immunogenicity assays for 351 (a) and 351 (k) biologics at CDER
Involved in writing FDA Immunogenicity guidances
Immunogenicity Working Group
FDA Immunogenicity Guidances
Guidance (2014): Immunogenicity Assessment for Therapeutic Protein Product
Discusses product and patient risk factors that may contribute to immune response rates.
Draft Guidance (2016): Assay Development for Immunogenicity Testing of Therapeutic Proteins
Discusses the development and validation of immunogenicity assays
Guidance (2016): Immunogenicity-Related Considerations for Low Molecular Weight Heparin
Provides recommendations on addressing impurities and their potential effect on immunogenicity for ANDAs
Guidance (2015): Scientific Considerations In Demonstrating Biosimilarity To A Reference Product
Discusses immunogenicity assays in context of 351(k) pathway
Guidance (2017): Considerations in Demonstrating Interchangeability to a Reference Product
Discusses immunogenicity studies required for interchangeability in context of 351(k) pathway
Draft Guidance (2017): A