Ozempic is shown at a pharmacy in Toronto on Wednesday, April 19, 2023. The Canadian Press
Canada has cleared the path for lower-cost versions of Ozempic, but patients should not expect immediate access.
While generic production of semaglutide is now permitted, experts say pharmacy shelves are unlikely to stock the drug for several months due to regulatory and manufacturing timelines.
Generic Applications Now Under Review
Federal regulators have received nine submissions from pharmaceutical companies seeking approval to produce generic semaglutide.
Several major drugmakers are among the applicants, though none have confirmed when their products may reach the market.
Regulators say all applications must undergo full scientific review before approval.
Why Approval Will Take Time
Health experts say generic semaglutide is more complex to approve than most medications.
Although generics are typically chemically identical to brand-name drugs, semaglutide was originally developed using biological processes. Generic versions are produced differently, requiring additional testing to confirm safety, quality, and effectiveness.
Health Canada’s standard review timeline for generic drugs is about 180 days. That timeline can extend if regulators request additional data from manufacturers.
No Immediate Relief At Pharmacies
Despite regulatory clearance allowing companies to manufacture generics, pharmacists say patients should not expect availability in January.
Industry analysts estimate the earliest approvals could arrive in late spring or early summer.
Until then, patients will continue relying on brand-name Ozempic and Wegovy.
Lower Prices Expected Once Generics Launch
Once approved, generic semaglutide is expected to cost significantly less than the brand-name versions.
Experts say prices could fall to roughly 35 per cent of current costs. Monthly expenses that now run into the hundreds of dollars may become more affordable for patients managing Type 2 diabetes or obesity.
Doctors Welcome The Shift
Medical specialists say cost remains the biggest barrier preventing patients from accessing semaglutide.
Many patients who could benefit from the drug are unable to afford it, even when clinically recommended.
Physicians say broader access could improve treatment outcomes and reduce long-term health risks.
Brand-Name Drugs Remain Available
Novo Nordisk, which manufactures Ozempic and Wegovy, says it will continue supplying the drugs in Canada.
The company has also committed to providing financial assistance for some patients without insurance coverage.
More than one million Canadians currently use the brand-name medications.
Competition Remains Limited
Canada is currently the only country where Novo Nordisk’s semaglutide patent has expired.
Meanwhile, rival diabetes and weight-loss drugs using different active ingredients remain under patent protection, meaning generic alternatives are not expected soon.
For now, patients seeking lower-cost options will need to wait — even as the groundwork for generics is finally in place.
