Canada sees generic semaglutide on shelves

Canadian pharmacies have begun stocking generic semaglutide, weeks after Health Canada approved the first two copy versions of Novo Nordisk’s Ozempic. CBC News reported on May 20 that some pharmacies already have supply on shelves, citing a spokesperson for Dr. Reddy’s Laboratories. Health Canada approved Dr. Reddy’s product on April 28 and approved a second generic, from Toronto-based Apotex, on May 1. The approvals made Canada the first G7 country to authorize a generic version of semaglutide, the regulator said. ### Which companies have approvals, and who is already selling? Dr. Reddy’s Laboratories said on May 16 that it had launched its generic semaglutide injection in Canada, days after receiving a Notice of Compliance from Health Canada on April 28. CBC reported that Dr. Reddy’s told it by email that the product launched in Canada last week and was available in select pharmacies, with broader national distribution expected in the coming days. (cbc.ca) Apotex said on May 1 that Health Canada had approved Apo-Semaglutide Injection, a generic equivalent of Ozempic, and that it expected to bring the product to market “in the very near future.” CBC separately reported that Apotex expected availability within weeks. (pharmiweb.com) ### Is the generic the same as Ozempic? Health Canada said the approved generic semaglutide injections are “pharmaceutically equivalent” to the brand-name product and that its review found they met the agency’s standards for safety, efficacy and quality. The department also said the products are complex synthetic medicines and that its review is intended to ensure any differences do not affect safety, efficacy or quality. (apotex.com) CBC reported that the approved generics are injectable semaglutide products for adults with type 2 diabetes, the same core indication carried by Ozempic in Canada. Dr. Reddy’s and Apotex both said their products are supplied in pre-filled pen formats, including 2 mg and 4 mg presentations that deliver the same weekly dose steps used by the brand product. (canada.ca) ### How much could patients save? Health Canada said many generic medicines in Canada are priced 45% to 90% below brand-name products, but it did not set a specific semaglutide price in its release. CBC reported that brand-name Ozempic can cost about C$300 to C$400 a month, sometimes more, depending on dose. (cbc.ca) CBC also reported that, under pan-Canadian Pharmaceutical Alliance pricing rules cited by experts, a first generic can be priced at 75% to 85% of the brand, a second entrant can bring both to 50%, and three or more generics can push prices to about 35% of the brand-name level. Those figures describe the pricing framework, not a confirmed shelf price at any one pharmacy. (canada.ca) ### Does approval mean pharmacists can automatically substitute it? Provincial formularies and pharmacy rules still matter after federal approval. Health Canada’s authorization means the products can be sold in Canada, but public-plan listing, private-plan reimbursement and interchangeability decisions are handled through provincial or plan-specific systems. Ontario’s formulary, for example, separately tracks whether a product is designated interchangeable. (cbc.ca) Apotex said it was working with insurers to secure coverage, and CBC reported that private plans often add generics shortly after launch. That means the pace of savings for patients may depend on province, pharmacy and insurance coverage as much as on federal approval. ### What comes next in Canada’s rollout? Health Canada said on May 1 that it was reviewing seven other generic semaglutide submissions from different companies. (canada.ca) The department said it expected to make more regulatory decisions in the coming weeks and months and would continue monitoring the safety and effectiveness of authorized products. (cbc.ca) The next concrete steps are provincial formulary updates, insurer coverage decisions and wider pharmacy distribution by the two approved manufacturers. Dr. Reddy’s has already begun shipping, while Apotex has said its launch is expected in the near term. (pharmiweb.com) (canada.ca)