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.
Lee et al. (2026) studied this question.