Apotex gains Health Canada approval for Apo‑Semaglutide Injection™, the first Canadian‑based company’s generic equivalent of Ozempic® (semaglutide), offering once‑weekly treatment for type‑2 diabetes with 2 mg and 4 mg pen options.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Apotex has received Health Canada approval for Apo‑Semaglutide Injection™, a generic equivalent of Ozempic® (semaglutide injection). The authorization marks the first time a Canadian‑based pharmaceutical company has secured approval for a generic version of semaglutide in Canada.
Apo‑Semaglutide Injection was developed in partnership with Orbicular Pharmaceutical Technologies and underwent Health Canada’s standard regulatory review for peptide medicines. The product is approved for once‑weekly subcutaneous use in adults with type‑2 diabetes mellitus to improve glycemic control when used in combination with diet and exercise.
The approval includes two prefilled pen formats aligned with the reference product:
- A pen delivering 0.25 mg or 0.5 mg doses (2 mg total; 0.68 mg/mL)
- A pen delivering 1 mg doses (4 mg total; 1.34 mg/mL)
Apotex states this will be the first Canadian generic equivalent to offer both the 2 mg and 4 mg pen presentations commercially, matching all brand‑equivalent SKUs.
Martin Arès, President of Apotex Canada and Rest of World, said the approval supports the company’s goal of improving access to medicines in Canada by providing a high‑quality, more affordable treatment option while supporting long‑term healthcare system sustainability.
Dr. M. S. Mohan, Managing Director at Orbicular Pharmaceutical Technologies, noted the approval reflects the strength of the company’s peptide development platform and the scientific collaboration required to meet Health Canada’s regulatory standards.
Apotex emphasized its continued focus on expanding access to essential medicines through generic drug development. The company also advised healthcare professionals to consult the full product monograph for detailed safety information, including warnings, precautions, and adverse reactions.
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About the Writer
Farha Farheen, Pharm.D, is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.