Generic & Biosimilars

Generic and biosimilar competition shapes access with the post-IRA Medicare-negotiation environment changing economics. The session covers biosimilar interchangeability after FDA 2024 rule, complex generics development, generic launches in IRA Medicare-negotiation era, patent thickets and the IPR system, FDA Accelerated Generic pathway, and global biosimilar access. Discussion addresses US/EU/Asian biosimilar markets comparison, immunogenicity in switching studies, biosimilar acceptance research, biosimilar pharmacist role, and emerging next-generation biosimilars (long-acting GLP-1 biosimilars).