Health Canada approves Sandoz's generic semaglutide

Novo Nordisk maintains Ozempic supply as generic rivals reach the market

Health Canada approves Sandoz's generic semaglutide

Health Canada has issued a notice of compliance authorizing Sandoz Canada Inc. to market a generic version of semaglutide for adults with type 2 diabetes.  

According to the Sandoz Canada release, the product, marketed as Sandoz Semaglutide, is approved for once-weekly treatment to improve glycemic control, used in combination with lifestyle changes and other antidiabetic agents. 

The notice of compliance covers three doses delivered subcutaneously through two pen presentations, the release said: one pen delivers 0.25 mg or 0.5 mg doses from a 2 mg concentration of semaglutide (1.34 mg/mL), and the other delivers a 1 mg dose from a 4 mg concentration (1.34 mg/mL). 

Sandoz Canada received a Notice of Compliance for PrSandoz Semaglutide, a treatment for type 2 diabetes, Michel Robidoux, president and general manager of Sandoz Canada. 

With close to 12m semaglutide injection pens used annually in Canada, the company aims to "reduce barriers to access, both financially and in terms of supply." 

Sandoz Canada is preparing for the future commercialization of Sandoz Semaglutide and is developing educational materials and tools for patients and healthcare professionals ahead of launch. 

Novo Nordisk, in a separate statement, said it maintains an established supply of Ozempic across Canada amid increased demand for semaglutide and limited generic supply. 

Health Canada approved Ozempic in 2018, and more than 1m Canadians now use semaglutide. 

Iain Graham, general manager at Novo Nordisk, said in the statement that the company is prioritizing "a stable and continuous supply" of semaglutide for patients who choose Ozempic. 

Ozempic is indicated for the once-weekly treatment of adult patients with type 2 diabetes to improve glycemic control, and can be used with metformin, a sulfonylurea, a sodium-glucose cotransporter 2 inhibitor (SGLT2i) and basal insulin with metformin, according to the indications cited in the Novo Nordisk statement. 

The drug is also indicated as an adjunct to diet, exercise and standard of care to reduce the risk of major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction or nonfatal stroke, in adults with type 2 diabetes and established cardiovascular disease or chronic kidney disease. 

It is further indicated to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. 

Eligible Canadians with private drug coverage, as well as those paying entirely out of pocket, can access savings on Ozempic through the Ozempic Savings Card at pharmacies across Canada, excluding Quebec. 

Savings are also applied automatically through Novo Nordisk Care Rx, operated by Rexall, and through select online telehealth and retail partners.