Canada has become the first G7 nation to authorize a generic version of semaglutide injection, following regulatory approval of a pharmaceutical equivalent to the popular diabetes drug Ozempic. Health Canada announced on Tuesday that it had approved the submission from Dr. Reddy's Laboratories, a global pharmaceutical company headquartered in Hyderabad, India, with a U.S. base in New Jersey.
According to Health Canada, eight other generic versions of the drug are currently awaiting regulatory approval. The department stated that these complex synthetic products are considered pharmaceutically equivalent to the brand-name biologic drug.
Health Canada's Review Process
Health Canada's review process ensures that any differences between the generic and brand-name products do not compromise the drug's safety, efficacy, or quality. The department emphasized that the availability of generic drugs is expected to have a positive impact in Canada, potentially leading to cost savings for both patients and the healthcare system. Health Canada will continue to monitor the safety and effectiveness of all generic semaglutide products, as it does with all authorized drugs in the country.
Cost Implications of Generic Drugs
The generic version is used for weekly treatment of Type 2 diabetes in adult patients to help manage blood-sugar levels. Health Canada noted that many generic drugs are approximately 45% to 90% cheaper than their brand-name counterparts. In comparison, a prescription for Novo Nordisk's Ozempic, which has also gained attention for off-label weight loss use, can cost Canadians hundreds of dollars per month, according to The Canadian Press.
The cost of generic versions will depend on the number of approvals and market competition. Under the pan-Canadian Pharmaceutical Alliance pricing structure, a single-source generic product may be priced at about 75% to 85% of the brand-name product's price. Dual-source products could cost 50%, while multi-source products may drop to 25% to 35% of the brand-name cost.
Global Context and Patent Expiry
India approved two generic semaglutide drugs from Dr. Reddy's Laboratories in March after Ozempic's patent expired there. The company had submitted its product for review in Canada in 2024. This development marks a significant step in expanding access to affordable diabetes medications globally.
