Apotex becomes the first Canadian‑based pharmaceutical company to receive Health Canada approval for a generic equivalent of Ozempic®

TORONTO, May 1, 2026 /PRNewswire/ - Apotex Inc. ("Apotex" or the "Company"), Canada's largest Canadian‑based global health company, today announced that Health Canada has approved Apo‑Semaglutide Injection^TM, a generic equivalent of Ozempic® (semaglutide injection). As the first Canadian‑based pharmaceutical company to gain authorization for a generic equivalent of Ozempic®, this approval reinforces Apotex's leadership in bringing high‑quality, affordable alternatives to Canadians and reflects the Company's long‑standing commitment to strengthening access to essential medicines across the country. Apo-Semaglutide Injection will be the first Canadian generic equivalent to offer both the 2 mg/pen (0.68mg/mL) and 4 mg/pen (1.34 mg/mL) pen formats commercially, aligning with all brand equivalent SKUs.

Developed in partnership with Orbicular Pharmaceutical Technologies, Apo‑Semaglutide Injection has undergone Health Canada's standard regulatory review for peptide medicines.

The authorization includes two prefilled pen formats:

• A pen delivering 0.25 mg or 0.5 mg doses (containing 2 mg of semaglutide 0.68mg/mL)
• A pen delivering 1 mg doses (containing 4 mg of semaglutide 1.34 mg/mL)

In Canada, Apo‑Semaglutide Injection (semaglutide injection) is indicated for the once‑weekly treatment of adults with type 2 diabetes mellitus to improve glycemic control, in combination with diet and exercise. ¹

For more than 50 years, Apotex has played a central role in supporting the sustainability of Canada's healthcare system. The Company's medicines have generated significant savings for public and private drug plans, helping expand access to essential treatments.

"This approval reflects our Canadian roots and our commitment to improving access to medicines," said Martin Arès, President, Apotex Canada and Rest of World (ROW). "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."

"We are pleased to collaborate with Apotex on this important program," said Dr. M. S. Mohan, Managing Director, Orbicular Pharmaceutical Technologies. "The approval of Apo‑Semaglutide Injection demonstrates the strength of our peptide development platform and the disciplined scientific work undertaken by both teams to meet Health Canada's rigorous expectations."

Apotex remains focused on advancing trusted, high‑quality generic medicines that enhance patient access and contribute to a resilient Canadian healthcare landscape.

Healthcare professionals should consult the complete for detailed information on warnings, precautions, adverse reactions, and patient monitoring requirements.

About Apotex

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Learn more at www.apotex.com.

¹ Product Monograph: https://health-products.canada.ca/dpd-bdpp/

SOURCE Apotex Inc.