Apotex Health Corp. APTX-T has emerged as the only maker of generic Ozempic for Canadians for at least the next few months after a manufacturing issue at an Indian plant sidelined at least two competitors.
Ozempic, the brand name of the drug semaglutide made by Danish drug maker Novo Nordisk NVO-N, was the highest-selling drug in Canada last year with $2.9-billion in sales, according to aggregated prescription data collected by IQVIA Canada, an analytics company.
Ozempic is authorized for patients with type-2 diabetes, while a higher-dose formulation sold under the name Wegovy is authorized for weight management. More than one million Canadians took semaglutide last year.
Generic forms of semaglutide became legal in January after Novo Nordisk’s remaining market protections expired, and Health Canada began issuing approvals in late April: first for a generic manufactured by India’s Dr. Reddy’s Laboratories Ltd. and then for another made by Toronto-based Apotex Health Corp. South Africa’s Aspen Pharmacare Holdings Ltd. APNHY was approved July 17.
But earlier this month, Dr. Reddy’s disclosed to Indian investors that it discovered problems at a facility it was upgrading to produce more semaglutide to meet growing global demand for the drug.
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Erez Israeli, Dr. Reddy’s chief executive officer, told analysts on a July 9 call that the company found the level of impurities in the pharmaceutical ingredients produced at the facility were “out of specifications.”
He said it would take until late October or early November to fix the issues and finish testing, although he warned there was a risk of further delays.
Mr. Israeli said there was no recall concern because the supply of semaglutide sent to Canada did not come from the faulty batches. “Anything that was sent to the market is safe,” he said on the call.
Health Canada did not answer a question Tuesday about whether it had any concerns about Dr. Reddy’s semaglutide.
The manufacturing issue has also left Aspen in the lurch, which had been authorized to sell semaglutide through a licensing deal with Dr. Reddy’s. The company said in a notice last week that the timing of its launch will depend on the availability of semaglutide produced by Dr. Reddy’s.
That has left Apotex as the only supplier of generic semaglutide in Canada for now.
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“While we didn’t anticipate being the only generic available, we continue to work with our partners to increase our supply as we understand there remains a very strong demand, particularly as the product is now available at a fraction of the cost it was previously,” said Catherine Thomas, Apotex’s vice-president of global communications.
Key ingredients for Apotex’s semaglutide are also produced in India, through a partnership with Indian pharmaceutical company Orbicular Pharmaceutical Technologies.
David Martin, managing director and head of equity research at Bloom Burton Securities Inc., said this was “good news in the short-term for Apotex.”
Bloom Burton had forecasted the sales of Apotex’s semaglutide in Canada to be $124.4-million for the fiscal year ending March 31, 2027, but that assumed the generic market would be split with Dr. Reddy’s.
Fewer generic options also may be a boon for name-brand Ozempic.
Generic drugs tend to attract patients by offering lower prices. In Canada, generic prices are set out in a formula agreed to by insurance plans and drug makers. For injectable drugs where there are at least three manufacturers on the market, prices have a ceiling of 35 per cent of the name brand price.
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The current list price of name-brand Ozempic is $228 for a four-week supply, while the products from Apotex and Dr. Reddy’s are priced at $78. Those prices are before markups from pharmacies and distributors, but also before any manufacturer discounts.
As generics have come on the market in recent months, Novo Nordisk has announced discount cards that would allow patients outside of Quebec, who are paying out of pocket or through private insurance, to pay generic prices for Ozempic.
Kate Hanna, director of communications at Novo Nordisk Canada, said the company could not share data on how many patients have stayed on the brand name.
She said Novo Nordisk has an established, stable supply of Ozempic for the Canadian market.
Most pharmacies and distributors contacted by The Globe and Mail said they have not yet seen any major disruptions to the supply of semaglutide, but are monitoring the situation.
“We work closely with all manufacturers of this therapy, and at this time we’re receiving adequate supply of semaglutide to support our patients,” said Youmna Rab, retail communications manager at Loblaw Companies Ltd.
Tom Elliott, medical director of BCDiabetes, a large clinic for people with diabetes in Vancouver, said his patients have had limited access to generic semaglutide so far and are sticking to the brand name.