Canada approves generic semaglutide injection

Health Canada has cleared Dr. Reddy’s Laboratories’ generic semaglutide injection, making Canada the first G7 country to approve a generic Ozempic copy. (canada.ca) The approval was announced April 28 in Ottawa. Health Canada said the product is indicated as a once-weekly treatment for adults with Type 2 diabetes to help manage blood sugar. (canada.ca) The submission came from Dr. Reddy’s Laboratories, and Health Canada said it reviewed evidence showing the drug met Canadian standards for safety, efficacy and quality. (canada.ca) Semaglutide is the active ingredient in Novo Nordisk’s Ozempic. It belongs to the glucagon-like peptide-1 class, a group of medicines used in diabetes care and, in other branded forms, weight management. (canada.ca) Health Canada said generic semaglutide is a “complex synthetic product” that must be shown to be pharmaceutically equivalent to the brand product, with no meaningful difference in safety, efficacy or quality. (canada.ca) The regulator said it completed review of Dr. Reddy’s filing within its 180-day target timeline. It also said many generic medicines in Canada are priced 45% to 90% below branded versions. (canada.ca) The timing follows a brief public delay. In an April 24 filing to India’s stock exchanges, Dr. Reddy’s said it had received Canadian drug identification numbers on April 22 but had not yet received the formal Notice of Compliance. (bseindia.com) That filing came after reports that approval was imminent. Dr. Reddy’s told investors it was still engaging with Health Canada and would bring the product to the Canadian market upon approval. (bseindia.com) The company had also been fighting a separate semaglutide patent dispute with Novo Nordisk in India. In a March 10 filing, Dr. Reddy’s said the Delhi High Court had allowed it to manufacture semaglutide in India for export to countries where Novo did not hold a patent registration. (bseindia.com) Health Canada said eight other generic semaglutide submissions are still under review and more decisions are expected in the coming weeks and months. That means Dr. Reddy’s approval may be the first move in a larger generic semaglutide rollout, not the last. (canada.ca)