Eight Generic Semaglutide Files Still Under Health Canada Review

Health Canada is currently reviewing eight additional generic semaglutide submissions following its April 28, 2026 authorization of Dr. Reddy's Laboratories' version, the first generic semaglutide approved in the G7.

The eight-file queue

Health Canada confirmed in its April 28 announcement that eight other generic semaglutide submissions from different companies remain under review, with regulatory decisions expected in the coming weeks and months. The department published the pending files on its generic submissions under review registry.

The Dr. Reddy's submission references the brand-name product Ozempic from Novo Nordisk and was authorized after Health Canada's review of safety, efficacy, and quality evidence for generic drugs.

Apotex authorization: full SKU parity

Apotex subsequently received Health Canada authorization for Apo-Semaglutide Injection covering both commercial pen configurations — the 2 mg/0.68 mg/mL and 4 mg/1.34 mg/mL formats — making it the only generic entrant to match every commercial SKU Novo Nordisk currently offers in the Canadian market.

The Apotex file moved through Health Canada's standard review pathway for peptide medicines rather than an abbreviated stream, reflecting the higher analytical burden for demonstrating bioequivalence of injectable peptides. Apotex partnered with Orbicular Pharmaceutical Technologies, an Indian peptide-specialist firm, to meet that standard.

Apotex has not announced a commercial launch date beyond "very near future," leaving provincial formulary listing decisions as the key variable determining actual pharmacy availability.

Novo Nordisk's parallel brand strategy

Ahead of generic competition, Novo Nordisk secured Health Canada approval to market semaglutide under two new brand names: Plosbrio and Poviztra. The company is considering using these products to compete in the generic market in Canada, while Ozempic and Wegovy would likely maintain higher brand-name prices.

What the authorizations cover

The Dr. Reddy's and Apotex authorizations reference the labelling of the branded Ozempic product from Novo Nordisk. Wegovy — semaglutide at the 2.4 mg weekly dose — is a separate Health Canada authorization not covered by these generic approvals.

Patient guidance published after the April 28 announcement notes that in most Canadian provinces a pharmacist can substitute a generic version without a new prescription, provided the prescriber has not written "no substitution" or "dispense as written" on the original.

Pricing framework

Generic pricing in Canada follows a tiered framework set by the pan-Canadian Pharmaceutical Alliance, with the first generic priced at a percentage of the brand-name reference and prices dropping in steps as more manufacturers reach pharmacy shelves. Coverage adjustments by private insurers and provincial drug plans typically lag the price change by weeks to months.

Readers can monitor developments through our generic semaglutide tracker, the insurance coverage checker, and the FAQ. Comparative price listings for Mounjaro, Zepbound, and Rybelsus are updated as pharmacies confirm figures.

This article is for informational purposes only and does not constitute medical advice.

Sources

• Canada becomes the first G7 country to approve a generic ...
• Apotex Gets Health Canada Approval for Generic ...
• Canada Approves Novo Nordisk Generics
• Generic Semaglutide in Canada: A Patient Guide