Drug firms in Canada are allowed to make decrease priced generic variations of the blockbuster drug Ozempic as of subsequent week, however consultants say sufferers shouldn’t count on it to be accessible for no less than just a few months.
As of Dec. 29, Well being Canada had acquired 9 submissions searching for approval to make semaglutide, the lively ingredient in Ozempic and Wegovy, the brand-name diabetes and weight-loss medication manufactured by Novo Nordisk.
“Well being Canada understands that there’s appreciable curiosity in reducing prices related to this extremely prescribed drug by introducing generic variations,” spokesperson Mark Johnson mentioned in an e-mail to The Canadian Press.
Sandoz Canada, Apotex, Teva Canada, Taro Prescribed drugs and Aspen Pharmacare Canada have all utilized for Well being Canada authorization, in accordance with its record of generic submissions.
Sandoz Canada and Teva Canada advised The Canadian Press they couldn’t present any data on anticipated timelines for his or her merchandise, whereas the others both couldn’t be reached or didn’t reply to requests for remark.
The remaining firms weren’t named as a result of their submissions have been acquired previous to April 1, 2024, when the coverage requiring a sponsor title modified, Johnson mentioned.
Mina Tadrous, a pharmaceutical coverage professional on the College of Toronto, mentioned a generic semaglutide medicine is unlikely to be accredited till late spring or early summer season.
“Canadians shouldn’t be anticipating a product in January,” he mentioned.
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Based mostly on generic pricing fashions in Canada, sufferers can count on the drug to be priced as little as 35 per cent of the brand-name Ozempic price, which generally is a few hundred {dollars} a month, Tadrous mentioned, noting that there’ll possible be a number of generic semaglutide drugs competing with one another.
The “goal timeline” for Well being Canada’s scientific evaluation of generic drug submissions is 180 days, Johnson mentioned.
That doesn’t embrace the additional time required if Well being Canada wants extra data from the drug firm.
Evaluating generic semaglutide medication is extra advanced than many different medicine approvals, he mentioned.
That’s as a result of semaglutide was initially developed utilizing organic processes, however the generic variations could be made utilizing extra easy chemical means.
“Generic semaglutide merchandise are advanced artificial merchandise which can be pharmaceutically equal to the model title drug, however with potential variations that might affect security and efficacy,” Johnson mentioned.
“The producer should present that these variations don’t have an effect on the protection, efficacy, or high quality of the drug in comparison with the model title drug.”
Dr. Ehud Ur, an endocrinologist in Vancouver, mentioned having the ability to prescribe generic semaglutide might be “very thrilling,” noting that semaglutide could be an efficient medicine for a lot of of his sufferers, however they aren’t on it as a result of they’ll’t afford it.
“The worth might drop fairly sharply and develop into fairly inexpensive for folks with Sort 2 diabetes and weight problems,” he mentioned.
“I’d say that the most important barrier to (taking) Ozempic isn’t negative effects or worries about its efficacy however its price,” Ur mentioned.
“While you’re speaking about two, three, 4 hundred {dollars} a month, (for) lots of people, , that’s simply unimaginable.”
Ur mentioned generics ought to “theoretically” be the identical because the model title, however often sufferers don’t have pretty much as good a response to generic drugs so might resolve to stick with the unique.
Canada is the one nation the place Novo Nordisk allowed the patent for its semaglutide medication to run out, paving the best way for “regulatory exclusivity” to finish on Jan. 4.
In an interview with The Canadian Press in late December, Novo Nordisk Canada president Vince Lamanna declined to present any particulars concerning the patent lapse, citing mental property confidentiality.
Lamanna mentioned greater than 1,000,000 sufferers in Canada are taking the brand-name drugs.
“No matter what occurs in January or by 2026, we’re dedicated to supporting sufferers on semaglutide — and that features each Ozempic and Wegovy — and to persevering with to make it accessible,” he mentioned, noting that the corporate will present “monetary and financial savings help” to some sufferers who don’t have insurance coverage protection and don’t need to change to a generic model.
Eli Lilly, Novo Nordisk’s principal competitor for diabetes and weight reduction medicine, nonetheless holds its patent in Canada and there’s no imminent patent expiry for its medication: Mounjaro and Zepbound.
The lively ingredient in these medication is tirzepatide, which like semaglutide acts on glucagon-like peptide-1 (GLP-1) hormone receptors, but in addition targets glucose-dependent insulinotropic polypeptide (GIP) receptors.
“Lilly stays assured within the differentiated advantages of tirzepatide, the primary and solely twin GIP/GLP-1 receptor agonist accredited to deal with adults with weight problems and adults with sort two diabetes,” the corporate mentioned in an e-mail assertion to The Canadian Press.
The assertion didn’t deal with questions on whether or not or not Eli Lilly would offer price financial savings to sufferers with a view to compete with generic semaglutide.
