Home / Health / Generic Ozempic Gets Canada Green Light
Generic Ozempic Gets Canada Green Light
6 May
Summary
- Health Canada approved a generic semaglutide injection developed in India.
- This marks the second G7 approval after the US FDA's tentative greenlight.
- The product will be marketed by Apotex in Canada, a major semaglutide market.
Orbicular Pharmaceutical Technologies announced that a generic semaglutide injection has received a Notice of Compliance from Health Canada. This marks a significant regulatory achievement, being the second stringent regulatory authority (SRA) in the G7 to approve the program after the U.S. FDA's tentative approval earlier this year.
The development represents a fully indigenous Indian innovation, with the active pharmaceutical ingredient (API), pen device, formulation, manufacturing, and analytical technology developed end-to-end within India. The product will be marketed and commercialized in Canada by Apotex Inc., Canada's largest pharmaceutical company.
Health Canada's authorization covers two presentations, matching the reference product's specifications. This approval is particularly impactful given that an estimated 3.9 million Canadians have diagnosed diabetes, and Canada is a major global market for semaglutide. The immediate availability of this generic alternative is anticipated to offer substantial benefits to patients, payers, and the healthcare system.
Dr. M. S. Mohan, Managing Director of Orbicular, highlighted the approval as a testament to the company's advanced capabilities in complex peptide development. He emphasized the integrated approach across formulation, analytics, and regulatory strategy that enables rapid and reliable market entry for technically complex products. Orbicular sees peptides as a strategic growth area, with Semaglutide being the first of several pipeline programs targeting global regulated markets.
Martin Arès, President of Apotex Canada and ROW, expressed pride in bringing a high-quality, affordable alternative to the Canadian market, underscoring Apotex's commitment to improving medicine access and supporting healthcare system sustainability.
