Six more generic files sit with Health Canada as plan sponsors wait on GLP-1 savings
A Polish drugmaker's experimental generic semaglutide matched Novo Nordisk's Ozempic and Wegovy on absorption in an early-stage bioequivalence study conducted in Canada.
Celon Pharma said the trial enrolled 91 healthy volunteers and showed a 0.5 milligram dose of its product, Reduzek, had a comparable rate and extent of absorption to the two branded drugs, Reuters reported on August 20.
Shares in the company surged 14.7 percent after it published selected data and were on track for their best trading day since July 2024 if the gains held, according to Reuters.
The results will allow the company to extend the demonstrated bioequivalence to other doses under clinical guidelines, Celon Pharma said in the same report.
The company said the trial marks a significant step in its strategy to launch the semaglutide equivalent in global markets.
Health Canada approved a generic semaglutide injection filed by Dr. Reddy's Laboratories on April 28 for the once-weekly treatment of adults with type 2 diabetes.
The approval made Canada the first G7 country to authorise a generic version of the drug, Benefits and Pension Monitor reported.
Health Canada authorized a second generic, from Toronto-based Apotex, on May 1.
On June 29, the regulator cleared Apotex's Sevmia, the first generic semaglutide indicated for chronic weight management in patients aged 12 and over, and said six other generic semaglutide submissions remain under review.
Apotex launched Apo-Semaglutide Injection commercially in Canada on May 14, the company said in a release.
Dr. Reddy's launched its own generic on the same date, according to Pearce IP, which also listed AA Pharma, Aspen Pharmacare, Teva, Taro Pharmaceuticals, Zydus Lifesciences, and Sandoz among the manufacturers with submissions before Health Canada.
The list price of brand-name Ozempic is $228 for a four-week supply before pharmacy and distributor markups, The Globe and Mail reported in May.
Health Canada has said many generic medications in Canada sell for 45 to 90 percent below their brand-name equivalents.
Plan sponsors have not yet rebuilt drug plan design around the rollout, Benefits and Pensions Monitor reported this month.
Alex Carducci, assistant vice president of pharmacy benefit management at Equitable, in comments cited by Benefits and Pensions Monitor the generic wave is a rare counterweight to specialty drug spending, and that plans "get to talk about some relief with the generics coming to market."
Sunil Hirjee, vice president of group sales and partner experience for Ontario, Western, and Atlantic Canada at Beneva, described the response as largely unchanged, noted by Benefits and Pensions Monitor that generic substitution has been an established plan design strategy for more than 20 years.
Generic entry will ease costs only at the margins, according to an Alberta Blue Cross report covered by Benefits and Pensions Monitor in February, which found the GLP-1 pipeline expanding into metabolic dysfunction-associated steatohepatitis and obstructive sleep apnea alongside a second wave of products targeting obesity with cardio-renal and metabolic co-morbidities.
GreenShield recorded year-over-year cost growth of 44 percent for semaglutide in 2024, JP Girard, executive vice president and head of GreenShield Insurance, told Benefits and Pensions Monitor last year.
Celon Pharma did not appear among the manufacturers Pearce IP listed as having semaglutide submissions before Health Canada, and the company did not identify which markets it will file in first in the Reuters report.
