Health Policy paper blames Canada's 114-day generic semaglutide delay on missing equivalence rules

The wire

1. 01Authors find neither Health Canada nor manufacturers missed a deadline; the delay came from settling, review round by review round, how a fully synthetic semaglutide matches a semisynthetic reference product.
2. 02Out-of-pocket Canadians paid more than $160 extra per month for roughly four months, and public payers lost discounts obscured by confidential rebate agreements.
3. 03The authors urge regulators to publish up-front equivalence standards for complex generics, starting with synthetic peptides, before further peptide exclusivities lapse; this is analysis, not new regulatory action.

From the source

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

Health policy (Amsterdam, Netherlands) · 2026 Sep 23 · Eisenkraft Klein D, Kesselheim AS et al.