Supply shortage from India keeps the cheaper diabetes drug off shelves until late October
A generic version of Novo Nordisk's diabetes drug Ozempic has cleared Health Canada, though a supply shortage will keep it off Canadian shelves for months.
South Africa's Aspen Pharmacare said on Monday that its Canadian subsidiary won regulatory approval for Aspen-Semaglutide, according to Reuters.
The drug is authorized to manage type 2 diabetes, the company said in a statement.
But Aspen's launch depends on supply.
The company said the timing of its commercial rollout in Canada hinges on securing semaglutide active pharmaceutical ingredient (API) from India's Dr Reddy's Laboratories, as per Reuters.
An API is the compound that produces a drug's therapeutic effect.
That ingredient is not coming soon.
Dr Reddy's said earlier this month that its generic semaglutide would stay unavailable in India and face disruptions in Canada until at least late October, Reuters reported, after an impurity in the active ingredient halted production of new batches.
Semaglutide is the active ingredient in Novo Nordisk's GLP-1 drugs Ozempic, for diabetes, and Wegovy, for weight loss.
The expiry of Novo's patent on the compound has opened the Canadian market to generic manufacturers, whose products copy branded drugs, according to BNN Bloomberg.
Aspen has already set out where it will make the medicine.
Chief executive Stephen Saad said in March that the company would manufacture its generics at plants in South Africa and France, BNN Bloomberg reported.
The South African site will handle larger volumes of multi-dose pens, while the French facility will produce single-dose autoinjectors, Saad said.
