Interchangeability requires demonstrating that switching between the reference biologic and the biosimilar produces no greater safety or efficacy risk than remaining on the reference product
This includes Ozempic, Wegovy, and Rybelsus, each of which has unique characteristics
First, the endogenous peptide must exhibit reproducible physiological effects supported by genetic, pharmacologic, or observational evidence
The FDA signaled escalating enforcement, and on April 30, 2026, it proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B outsourcing facility bulks list - the mechanism that governs which substances large-scale compounders may use - with a public comment period open through June 29, 2026