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Canada leads G7 with generic GLP-1 drug approval
Canada has become the first G7 nation to authorize generic versions of semaglutide, the active ingredient in weight-loss and diabetes medications like Ozempic and Wegovy. The lower-cost alternatives, expected in pharmacies this month, could reduce prices by more than two-thirds for the three million Canadians using these drugs.
High costs force patients to make tough choices
Elizabeth Doran, a 69-year-old retiree in Ottawa, has relied on Wegovy for nearly a year to manage prediabetes and high blood pressure. Despite its effectiveness, the medication cost her between C$350 and C$500 monthly-expenses she covered by working substitute teaching shifts and using manufacturer discounts. Because she isn't diabetic, her insurance didn't cover the drug.
Doran's experience reflects a broader challenge: many Canadians and Americans struggle to afford GLP-1 medications, which can exceed US$1,000 per month in the U.S. without insurance. In Canada, provincial coverage is typically limited to diabetic patients, leaving others to pay out of pocket.
Generics arrive as Novo Nordisk slashes brand-name prices
Health Canada has approved generic semaglutide injections from two manufacturers: India-based Dr Reddy's and Canadian firm Apotex. Both versions are approved for type 2 diabetes but can be prescribed off-label for weight loss. The generics' arrival has already prompted Novo Nordisk to reduce its brand-name drug prices in Canada and other markets, including India, where costs were cut by nearly 50%.
Erez Israeli, CEO of Dr Reddy's, told the BBC his company is pursuing approvals in over 80 countries, including South America, Africa, and Asia. However, the U.S. and Europe remain off-limits due to patent protections. Apotex, meanwhile, has secured tentative FDA approval but cannot yet sell its generic in the U.S.
Patent barriers delay U.S. access to generics
Tahir Amin, founder of the U.S.-based Initiative for Medicines, Access & Knowledge (I-MAK), explained that Americans won't see generic semaglutide until at least 2032, when the drug's primary patent expires. The U.S. and Europe allow extended monopolies to compensate for regulatory delays, a system Amin calls the "Golden Egg" of the pharmaceutical industry, heavily protected by lobbying and litigation.
Novo Nordisk's failure to renew its Canadian patent for Ozempic-originally set to expire in 2028-accelerated generic approvals there. The company attributed the situation to "localized" patent timelines, emphasizing that its U.S. exclusivity remains intact.
Cross-border demand and ethical concerns
Canada's lower drug prices have long attracted American buyers. In 2019, a group of U.S. activists traveled to Canada to purchase affordable insulin, protesting high costs at home. More recently, British Columbia restricted Ozempic sales to Americans after discovering 15% of prescriptions were filled for U.S. patients, primarily through online pharmacies. Former provincial health minister Adrian Dix condemned the practice, stating, "The purpose of procuring Ozempic for British Columbia patients is not to turn around and export it right back to the United States."
Apotex CEO Martin Arès confirmed his company is exploring ways to supply its generic semaglutide to Americans but cautioned it wouldn't reach the U.S. market this year. "We remain committed to bringing this product as soon as possible," he said.
Patients celebrate affordability breakthrough
For Doran, the generic drugs represent a lifeline. "It's huge," she said, noting she's already seen Wegovy's price drop. "By taking this drug, I'm probably saving the healthcare system a lot of money," she added, citing reduced risks of diabetes and heart disease.
Esther Linetsky, another Canadian patient, was forced to ration her Ozempic doses due to cost. "My doctor wanted me to increase my dose, but I couldn't afford it," she said. With generics now available, she hopes to use the medication as prescribed without financial strain.
Amin warned that high U.S. prices have created a two-tier system, where only wealthier patients can access GLP-1 drugs. "People who especially need it to manage diabetes are left unable to secure it," he said, calling patent reform an "uphill battle" against pharmaceutical industry resistance.