Diabetes Treatment Access Expands with New Canada Approval

Diabetes treatment access is set to improve in Canada after Orbicular Pharmaceutical Technologies announced it has received a Notice of Compliance (NOC) from Health Canada for its semaglutide injection, developed in partnership with Apotex Inc..

The product is a generic version of Ozempic and will be commercialized across Canada by Apotex. The approval includes two presentations—2 mg/3 mL (0.68 mg/mL) and 4 mg/3 mL (1.34 mg/mL)—matching the reference product’s concentration and fill volume.

This alignment ensures a smooth transition for both patients and prescribers already familiar with the therapy. With nearly 3.9 million Canadians living with diabetes and the country ranking as the world’s second-largest market for semaglutide, the launch is expected to ease access and reduce cost pressure.

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This latest milestone follows the U.S. Food and Drug Administration granting Tentative Approval earlier this year. Securing back-to-back authorizations highlights the strength of Orbicular’s development program, especially in a category known for technical hurdles. Health Canada has noted that generic semaglutide must match the original in safety, efficacy, and quality—standards that have historically slowed competition.

Orbicular said its integrated approach—combining advanced analytics, peptide expertise, and regulatory execution—helped overcome these challenges. The company also confirmed that commercial inventory is ready, allowing for near-term availability.

Dr. M. S. Mohan, Managing Director, Orbicular Pharmaceutical Technologies, said: "Receiving Notice of Compliance from Health Canada, following the U.S. FDA's Tentative Approval, is a significant milestone for Orbicular and reflects the depth of capability we have built in complex peptide development. "

Martin Ares, President, Apotex Canada and Rest of World (ROW), said: "This approval reflects our Canadian roots and our commitment to improving access to medicines. As a Canadian-based global health company, we are proud to bring forward a high-quality, affordable alternative that supports patients, prescribers, and the long-term sustainability of our healthcare system. We look forward to bringing this product to market in the very near future."