Aspen races to get Generic Ozempic approved in Canada by September

Stephen Saad has his eyes on Canada, and he’s not planning to wait long.

The chief executive of Aspen Pharmacare Holdings Ltd., Africa’s largest drugmaker, said Tuesday he expects Health Canada to greenlight his company’s generic version of semaglutide sometime between May and September. If that happens, Aspen will be among the first pharmaceutical companies to bring a copycat version of the blockbuster obesity and diabetes drug to market in one of the world’s most-watched regulatory battlegrounds.

“You want to be within, say, six months of a first launch, to be part of market formation,” Saad said in an interview.

Semaglutide is the active ingredient in Novo Nordisk’s Ozempic and Wegovy, two drugs that have reshaped conversations about obesity treatment and racked up massive global sales. Canada became the first major Western market to open the door to generics after Novo Nordisk’s core patent on the compound lapsed — the result of missed maintenance fee payments — and the data exclusivity protecting it from copycats expired Jan. 4.

Since then, the race has been on. Health Canada had received at least nine submissions for generic semaglutide approvals by late December, with filings from Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals and Aspen Pharmacare Canada among those in the queue. The regulator has a target review window of 180 days for generic submissions, though officials have said semaglutide is considered more complex than most generics, meaning timelines could stretch.

University of Toronto pharmaceutical policy expert Mina Tadrous said generic semaglutide was unlikely to hit pharmacy shelves before late spring or early summer.

That puts Aspen’s window squarely in the mix. Saad said a Canadian approval would matter well beyond Canada’s borders. Many countries in Latin America and the Middle East look to established regulators like Health Canada when making their own decisions.

“Once we get Canada registration, it means we can use it as a reference for a lot of our Latin American countries, Middle Eastern countries,” he said.

The prize in Canada alone is substantial. More than a million patients currently take Ozempic or Wegovy there. Industry analysts have projected that generic semaglutide, priced as low as 35% of the brand-name cost, could unlock access for patients who have been shut out by drug prices that run a few hundred dollars a month — a barrier that Vancouver endocrinologist Ehud Ur has described as “just impossible” for many of his patients.

Saad acknowledged the competition will be stiff. He expects somewhere between 12 and 15 manufacturers to eventually crowd into the generic GLP-1 space, pushing prices lower. But he said Aspen can compete aggressively on cost and still turn a profit.

“Absolutely can do that profitably,” he said of the Canadian market.

The longer-term opportunity, Saad suggested, may actually lie elsewhere. In emerging markets, where patients often pay entirely out of pocket, a cheaper price point could tap into demand that has never existed before.

“There are so many people that simply can’t afford to pay the price of branded products,” he said.

Aspen is not new to the GLP-1 space. The Durban-based company has an existing distribution deal with Eli Lilly and Co. to sell its competing weight-loss drug Mounjaro in South Africa, a partnership Saad said has been “a massive growth driver.” Eli Lilly still holds its Canadian patent on Mounjaro and its sister drug Zepbound, meaning it faces no imminent generic threat there.

The Durban company’s shares closed up 0.5% in Johannesburg on Tuesday, extending their year-to-date gain to 16%. Aspen earlier reported a 4.1% drop in first-half revenue to 21.1 billion rand, or about $1.3 billion.

Having invested heavily in manufacturing capacity for GLP-1 drugs and worked down its debt load, Aspen is now weighing how to allocate capital going forward. Saad said there are no plans for major acquisitions, but said the company could soon be discussing returning money to shareholders.

The broader stakes in Canada are not lost on the industry. Analysts and market watchers have described the country as a kind of proving ground — the first major test of how generics will disrupt a market that Novo Nordisk has dominated. Novo Nordisk has responded by securing approval to market semaglutide under the new names Plosbrio and Poviztra, which it may use to compete on price as generics arrive.

Globe and Mail reporting from earlier this year described Canada’s position plainly: the eyes of the global pharmaceutical industry are on this market.

Saad did not say whether Aspen would finish first or fourth. He said it didn’t much matter, so long as they were there.

“We might be first, we might be fourth, but we’ll be there,” he told reporters last month.