生物药物免疫原性评价的fda意见综述.pptx

Integrated Summaries of Immunogenicity:An FDA Reviewer’s Wish ListDisclaimerViews 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 BLAsFDA may include an ISI recommendation in new version of 2016 guidanceImmunogenicity at the FDAWho reviews it? Depends on the class of productCDER - monoclonal antibodies, growth factors, fusion proteins, cytokines, enzymes, therapeutic toxinsCBER- allergenics, blood and blood components including clotting factors, cellular and gene therapies, vaccinesOffice of Biotechnology Products (OBP)CMC for 351 (a) and 351 (k) biologics under CDER purview Currently 4 product divisions with mixed portfoliosCollaborate in immunogenicity risk assessments and review validation of clinical immunogenicity assays for 351 (a) and 351 (k) biologics at CDERInvolved in writing FDA Immunogenicity guidancesImmunogenicity Working GroupGuidance (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Draft Guidance (2016): Assay Development for Immunogenicity Testing of Therapeutic ProteinsDiscusses the development and validation of immunogenicity assaysGuidance (2016): Immunogenicity-Related Considerations for Low Molecular Weight HeparinProvides recommendations on addressing impurities and their potential effect on immunogenicity for ANDAsGuidance (2015): Scientific Considerations In Demonstrating Biosimilarity To A Reference ProductDiscusses immunogenicity assays in context of 351(k) pathwayGuidance (2017): Considerations in Demonstrating Interchangeability to a Reference ProductDiscusses immunogenicity studies required for interchangeability in context of 351(k) pathwayDraft Guidance (2017): ANDAs for Certain Highly Purifi