Delays in access to generic semaglutide point to key missing pieces in Canada's drug approval system

Canada approved its first generic version of semaglutide on April 28, 2026, 114 days after market exclusivity on the brand-name product expired and 26 months after the first generic company filed. Neither Health Canada nor the manufacturers appear to have missed a regulatory deadline. The delay arose because Health Canada had never set out how a manufacturer should establish that a fully synthetic semaglutide is the same drug as a semisynthetic reference product, so the agency and the companies settled that evidentiary standard one round of review at a time. Canadians paying out-of-pocket spent more than $160 extra per month across roughly 4 months, while public payers lost discounts that confidential rebate agreements make impossible to quantify. We argue that Health Canada should publish up-front equivalence standards for complex generic products, starting with synthetic peptides, so the next manufacturer can build the required evidence into its first submission. Any regulator that has not defined an equivalence standard for complex generics before the relevant exclusivities lapse may face similar delays, and a growing number of high-income countries will confront that question as peptide products lose protection.