Aspen's Generic Ozempic Gets Health Canada Approval, Launch Hinges on Dr Reddy's API Supply
Johannesburg: South Africa's Aspen Pharmacare said on Monday that its Canadian subsidiary had received regulatory approval from Health Canada for Aspen-Semaglutide, a generic version of Novo Nordisk's blockbuster diabetes drug Ozempic.
Africa's biggest pharmaceutical company said in a statement that its generic semaglutide is authorized for the management of type 2 diabetes.
The expiry of Novo's patent for semaglutide, the active ingredient in the Danish drugmaker's blockbuster GLP-1 drugs Ozempic for diabetes and Wegovy for weight loss, has opened the door for several drugmakers looking to enter the Canadian market with generic versions, which are essentially copies of branded drugs.
The timing of Aspen's commercial launch in Canada remains dependent on the availability of semaglutide active pharmaceutical ingredient (API) supply from India's Dr. Reddy's Laboratories, the company said.
An API is the key compound in a drug that produces its therapeutic effect.
Earlier this month, Dr Reddy's said that supplies of its generic semaglutide would remain unavailable in India and face disruptions in Canada until at least late October after an impurity issue in the drug's active ingredient halted production of new batches.
In March, Aspen's CEO Stephen Saad said Aspen's generics will be manufactured at its South African and French facilities, with the bigger volumes via multi-dose pens set to be produced at the South African facility.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.