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<p>On Oct 7 and 8, 2024, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) co-hosted a workshop titled “Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products”. Stakeholders from the FDA, industry, academia, and contract research organizations convened to discuss strategies for advancing risk assessment methodologies and regulatory frameworks for complex generic products. By assembling experts from various sectors, the workshop explored various available strategies for immunogenicity risk assessment, providing valuable insights to support the development and assessment of generic peptide and oligonucleotide drug products. The discussions fostered a deeper understanding of how these methodologies can inform regulatory decision-making and enhance the development of safer and more effective therapeutics.</p> Graphical Abstract <p></p>

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Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products

  • 期刊论文

  • 发表日期：

    2026年2月12日

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  • Jennifer K. Lee,
  • Ha-Na Lee,
  • Sudhir Agrawal,
  • Joseph A. Balsamo,
  • Andrew Clerman,
  • Sofie Denies,
  • Anne De Groot,
  • Jeremy Fry,
  • Nicolas Gaudenzio,
  • Andrew J. Graves,
  • Kristina E. Howard,
  • SuJin Hwang,
  • Vibha Jawa,
  • Yafei Jin,
  • Logan Kelly-Baker,
  • Emilee Knowlton,
  • Filip Kolenc,
  • Kirthiram Krishnaveni Sivakumar,
  • Jae H. Lee,
  • Yili Li,
  • Likan Liang,
  • Dahui Liu,
  • Yanyan Liu,
  • Robert Lionberger,
  • Markham C. Luke,
  • Mohanraj Manangeeswaran,
  • Mirian Mendoza,
  • Iilun Murphy,
  • Michael Norcross,
  • James E. Polli,
  • Montserrat Puig,
  • Narasimha Rao SP,
  • Hobart Rogers,
  • Anna Schwendeman,
  • Robert Siegel,
  • Sophie Shubow,
  • Noel Smith,
  • Seth G. Thacker,
  • Sophie Tourdot,
  • Kui Yang,
  • Li Zhang,
  • Deyi Zhang,
  • Cameron J. Smith,
  • Eric S. Pang,
  • Daniela Verthelyi

摘要

On Oct 7 and 8, 2024, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) co-hosted a workshop titled “Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products”. Stakeholders from the FDA, industry, academia, and contract research organizations convened to discuss strategies for advancing risk assessment methodologies and regulatory frameworks for complex generic products. By assembling experts from various sectors, the workshop explored various available strategies for immunogenicity risk assessment, providing valuable insights to support the development and assessment of generic peptide and oligonucleotide drug products. The discussions fostered a deeper understanding of how these methodologies can inform regulatory decision-making and enhance the development of safer and more effective therapeutics.

Graphical Abstract