Apotex Wins Health Canada Approval for Ozempic Equivalent — Weather Hamilton

weather hamilton Health Canada approved Apotex's Apo-Semaglutide Injection on May 1, 2026, clearing the Toronto company to sell a generic equivalent of Ozempic semaglutide injection in Canada. Apotex said the product is the first Canadian-based pharmaceutical company to win authorization for an Ozempic equivalent.

The approval gives Apotex a path to market a once-weekly treatment for adults with type 2 diabetes mellitus, with commercial plans for both 2 mg per pen and 4 mg per pen formats. Martin Arès, president of Apotex Canada and Rest of World, said the decision reflects the company’s Canadian roots and its effort to improve access to medicines.

Apotex and Orbicular

Apotex said Apo-Semaglutide Injection was developed with Orbicular Pharmaceutical Technologies. Dr. M. S. Mohan, managing director of Orbicular, said the companies were pleased to collaborate on the program and that the approval shows the strength of their peptide development platform and the work both teams put into meeting Health Canada’s expectations.

Health Canada reviewed the medicine under its standard regulatory review for peptide medicines. That review ended with authorization for a product Apotex described as a high-quality, affordable alternative for patients, prescribers, and the long-term sustainability of Canada’s healthcare system.

Two pen formats

The practical change for Canadian patients is the arrival of a second semaglutide option from a Canadian-based company, with both prefilled pen strengths planned for sale. Apotex said the medicine is indicated in Canada for the once-weekly treatment of adults with type 2 diabetes mellitus to improve glycemic control in combination with diet and exercise.

Arès said, “This approval reflects our Canadian roots and our commitment to improving access to medicines,” and added, “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.” He also said, “We look forward to bringing this product to market in the very near future.”

May 1, 2026

The immediate next step is commercial launch, which Apotex said it expects in the very near future. For patients and prescribers, the key change is not the approval itself but the added availability of a generic semaglutide option with two pen formats under the same Canadian authorization.