Ottawa (Rajeev Sharma): Health Canada is reviewing nine submissions for generic versions of popular weight-loss and diabetes medications, a move that could eventually reduce treatment costs for Canadians. The applications are for generic forms of semaglutide, the active ingredient used in Novo Nordisk’s branded drugs Ozempic and Wegovy, which are approved in Canada for diabetes management and weight loss.
Semaglutide belongs to the glucagon-like peptide-1 (GLP-1) class of medications that work by mimicking a natural gut hormone to control blood sugar levels, slow digestion and increase feelings of fullness. While effective, the drugs can cause side effects such as nausea, vomiting, diarrhea, stomach pain, fatigue, constipation and headaches.
Canada has become a key focus for generic drug makers because Novo Nordisk allowed its semaglutide patent to expire only in this country. With regulatory exclusivity ending on January 4, Canada could become the first market to offer lower-cost versions of Ozempic and Wegovy. However, pharmaceutical experts say the approval process is complex and cheaper options are unlikely to reach patients immediately.
Earlier this week, Novo Nordisk announced that a pill form of Wegovy has been introduced in the United States, starting with a lower dose. The company has not confirmed whether a similar application has been submitted in Canada. Health Canada said it does not comment on individual submissions unless they appear on its public list of drugs under review. Novo Nordisk already sells an oral semaglutide drug in Canada under the brand name Rybelsus for Type 2 diabetes.
Health Canada officials have said that reviewing generic semaglutide products is more complicated than many other drug approvals because the original medicine was developed using biological processes, while some generics are produced synthetically. Manufacturers must demonstrate that any differences do not affect the drug’s safety, effectiveness or quality.
Pricing of the generics will depend on several factors, including how many versions are approved, whether the medication is injectable or oral, and the dosage. Experts estimate that while Canadians currently pay between $200 and $400 per month for GLP-1 drugs, often out of pocket, the cost could fall to around $100 to $150 per month once multiple generic options enter the market. Even so, analysts believe approvals are more likely later in the year rather than in the early months.
Lower prices could significantly improve access for patients who are currently unable to afford these medications, which many obesity specialists consider an important tool in managing weight-related health conditions.
Companies that have submitted applications to Health Canada include Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals and Aspen Pharmacare Canada, while some applicants remain unnamed due to older disclosure rules.
