Canadian approval of semaglutide copy could lower GLP‑1 costs for plan sponsors
Canada could see one of the first generic versions of Ozempic on the market as early as this year, potentially reshaping access to GLP‑1 drugs.
According to Reuters, Aspen Pharmacare’s unbranded version of semaglutide — the active ingredient in Novo Nordisk’s Ozempic — could be registered in Canada in late Q2 or Q3, “so some time between May and September,” after Novo’s patent for semaglutide for diabetes in Canada expired in January and data exclusivity ended on January 4.
Reuters said Aspen hopes to be one of the first to provide generic competition for Ozempic in Canada.
As per Bloomberg, Aspen is targeting regulatory approval in Canada between May and September for its generic GLP‑1 obesity treatment and expects Canada will likely be the first market for its GLP‑1 product.
The core patent Novo first filed for semaglutide in March 2006 is expiring in countries where no extension was granted, with Canada the first to lose protection after missed maintenance fee payments.
Reuters said the launch would allow Aspen to tap into the booming weight‑loss drug market, which is estimated to reach at least $150bn by the end of the decade as demand for obesity treatments continues.
Bloomberg reported that Aspen sees GLP‑1s as “a durable long-term growth driver” and that Stephen Saad expects semaglutide generics to attract 12 to 15 manufacturers, with intensifying price competition.
According to Reuters, Saad said “Canada is very important for us” since many Latin American and Middle Eastern regulators use it as a reference for strict oversight.
He said the Canadian registration is aimed at easing entry into other emerging markets.
Bloomberg similarly reported Saad’s view that once Aspen gets Canada registration, it can use it as a reference for many Latin American and Middle Eastern countries, and that he expects quick uptake in Canada given the high penetration of other generic drugs.
Reuters reported that Aspen’s generics will be manufactured at its South African and French facilities, with bigger volumes via multi‑dose pens coming from South Africa and single‑dose autoinjector medicine produced in France.
Saad said there will be “a really big uptake, particularly in emerging markets” and “a lot of new patients on this product because it's affordable and because they will pay out of pocket,” while Bloomberg quoted him saying “there are so many people that simply can’t afford to pay the price of branded products.”
