Apotex Achieves Milestone as First Canadian Company Approved for Generic Ozempic Equivalent

Apotex Becomes a Pioneer in Generic Medicines with Health Canada Approval

In a significant advancement for the Canadian healthcare landscape, Apotex Inc. has proudly announced that it has become the first Canadian pharmaceutical company to gain Health Canada approval for a generic equivalent of Ozempic®, known as Apo-Semaglutide Injection. This announcement marks a pivotal moment, showcasing Apotex's enduring commitment to providing high-quality, affordable medications to Canadians.

The approval includes the introduction of Apo-Semaglutide Injection in two prefilled pen formats: one delivering 0.25 mg or 0.5 mg doses (2 mg of semaglutide at 0.68mg/mL) and another for 1 mg doses (4 mg of semaglutide at 1.34 mg/mL). This availability aligns perfectly with the existing brand equivalent SKUs, ensuring that patients will have various options to manage their treatment effectively.

Apo-Semaglutide Injection is specifically indicated for the weekly management of type 2 diabetes mellitus in adults, serving as a complementary solution alongside dietary and physical activity interventions aimed at improving glycemic control. As one of the leading medical companies in Canada for over 50 years, Apotex's development has resulted in considerable savings for both public and private drug plans, thereby enhancing access to treatment for many Canadians.

Martin Arès, the President of Apotex Canada, expressed pride in this new development, stating, "This approval reflects our Canadian roots and our commitment to improving access to medicines. We are proud to bring forward a high-quality, affordable alternative that supports patients, prescribers, and the long-term sustainability of our healthcare system."

This initiative is not only beneficial for patients but also represents a collaborative effort with Orbicular Pharmaceutical Technologies. Dr. M. S. Mohan, the Managing Director of Orbicular, noted, "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."

The introduction of Apo-Semaglutide Injection emphasizes Apotex's unwavering dedication to advancing trusted, high-quality generic medicines that enhance patient access. The healthcare community is encouraged to refer to detailed information regarding warnings, precautions, adverse reactions, and patient monitoring requirements.

About Apotex

Apotex is a leading Canadian global health company that ensures everyday access to affordable, innovative medicines and health products. With a diverse portfolio including a vast range of generic, biosimilar, and proprietary branded pharmaceuticals, Apotex continues to set the standard in the pharmaceutical industry. Headquartered in Toronto, with regional offices around the world, including in the U.S., Mexico, and India, Apotex remains a vital health partner for the Americas, advancing the availability of essential medications throughout the region.

For more information about Apo-Semaglutide Injection and other Apotex products, visit www.apotex.com.