Aspen Pharmacare wins Canada approval for generic Ozempic after Novo patent expiry
XLV•Launch timing depends on API supply
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.
Canada approval for Aspen-Semaglutide
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.
Generic competition follows patent expiry
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.
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.
The French facility will produce single-dose autoinjector medicine.
