Novo Nordisk Canada is considering competing with generic versions of its brand-name Ozempic and Wegovy drugs by introducing renamed, lower-priced copies of the medications.
Health Canada approved the company's submissions for Plosbrio and Poviztra on Dec. 22.
In an email, Health Canada spokesperson Mark Johnson said the diabetes and weight-loss drugs are identical to Ozempic and Wegovy, respectively.
The only differences are the product names and packaging, "with no changes to the formulation or how the drugs work," he said.
Health Canada is currently considering nine submissions from other drug companies to make generic semaglutide, the active ingredient in Ozempic, Wegovy, Plosbrio and Poviztra.
Experts have cautioned that generic semaglutide drugs — which are allowed in Canada after a lapsed patent paved the way for Novo Nordisk's regulatory exclusivity to expire on Jan. 4 — are unlikely to be approved for at least a few months.
Health Canada said evaluating them is complex because Novo Nordisk's products were developed using biological processes while the generic versions are made using chemical means.
"Generic semaglutide products are complex synthetic products that are pharmaceutically equivalent to the brand-name drug, but with possible differences that could impact safety and efficacy," Johnson said.
"The manufacturer must show that these differences do not affect the safety, efficacy or quality of the (generic) drug compared to the brand- name drug."
Because Novo Nordisk's Plosbrio and Poviztra are exactly the same as Ozempic and Wegovy, they didn't go through the same review process the generic versions do, Johnson said.
Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals and Aspen Pharmacare Canada have all applied for Health Canada approval of their generic versions, according to its list of generic submissions.
The remaining companies weren't named because their submissions were received prior to April 1, 2024, when the policy requiring a sponsor name changed, Johnson said.
Kate Hanna, spokesperson for Novo Nordisk Canada, said in an emailed statement on Tuesday that the company "is considering introducing a version of semaglutide to compete with generics once they enter the Canadian market."
Mina Tadrous, a pharmaceutical policy expert at the University of Toronto, called the potential move "an interesting play."
"Because of the pricing structure (in Canada) they can't really just lower the price of their brand-name product to allow generic market entry. So this is a way to kind of bypass that and stay competitive."
With the renamed and repackaged drugs, Novo Nordisk could implement a "new pricing strategy," Tadrous said.
Shelita Dattani, a pharmacist and health-care consultant, said such a strategy would not be unprecedented, but it would be "unusual."
From a patient perspective, increased competition — whether it's from generic companies or from lower-priced "branded options" by Novo Nordisk — would be welcome, she said.
"At the end of the day, I think it's great that we have broader access and better affordability for people who need these drugs, which has not to date been the case," Dattani said.
Ozempic and Wegovy can cost hundreds of dollars a month, but Hanna said many Canadian patients don't pay that out of pocket.
"Ozempic is covered by the majority of private insurance plans and is included in all government-sponsored drug plans for adults diagnosed with Type 2 diabetes," Hanna said.
"While Wegovy is not covered by government-sponsored public drug plans, it has strong private insurance coverage, and we continue to work to increase coverage for Canadians living with obesity."
In an interview with The Canadian Press in December, Novo Nordisk Canada president Vince Lamanna said more than a million patients in the country take the medications and the company provides "financial and savings support" to some patients who don't have insurance coverage.
Picture Courtesy: THE CANADIAN PRESS/Cole Burston
