{"id":496702,"date":"2026-01-06T14:49:14","date_gmt":"2026-01-06T14:49:14","guid":{"rendered":"https:\/\/www.europesays.com\/us\/496702\/"},"modified":"2026-01-06T14:49:14","modified_gmt":"2026-01-06T14:49:14","slug":"novo-nordisk-prepares-new-cheaper-version-of-ozempic-as-generics-face-delays","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/496702\/","title":{"rendered":"Novo Nordisk prepares new cheaper version of Ozempic as generics face delays"},"content":{"rendered":"<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/SGVLTUHJ7BBC3KNPVCHRCHBRLY.jpg?auth=9d8967b02cb130704eccbb00f6f0ae81c42e853546270181da49d19e6289dad0&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"0\" target=\"_blank\" rel=\"noopener\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Health Canada has received nine applications from five named companies to sell duplicates of semaglutide, the active ingredient in Ozempic.JOEL SAGET\/AFP\/Getty Images<\/p>\n<p class=\"c-article-body__text text-pr-5\">Danish drug maker Novo Nordisk is preparing to introduce a new version of its blockbuster drug Ozempic to compete with cheaper generics that became legal on Monday, but which are not expected to hit shelves immediately because of delays at Health Canada.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Ozempic is one of the most-prescribed drugs in Canada, with more than a million<b> <\/b>people taking it, according to<b> <\/b>Novo Nordisk. It was the highest-selling drug by revenue in the country last year.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Anticipation has been building for months about the launch of generic Ozempic in Canada, the first country where official copies of the top-selling medication can be sold legally. The last legal barriers preventing generic Ozempic expired on Sunday.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Health Canada has received <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drug-health-product-review-approval\/generic-submissions-under-review.html\" rel=\"noopener\" title=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drug-health-product-review-approval\/generic-submissions-under-review.html\" target=\"_blank\">nine applications<\/a> from five named companies to sell duplicates of semaglutide, the active ingredient in Ozempic, which is marketed for Type 2 diabetes, and Wegovy, a higher-dose version approved specifically for weight loss. None had received approval as of Monday.<\/p>\n<p class=\"c-article-body__text text-pr-5\">In the meantime, Novo Nordisk is preparing to launch new drugs that are medically identical to Ozempic and Wegovy, but sold under new names and likely at a lower price.<\/p>\n<p class=\"c-article-body__text mv-16 l-inset text-pb-8\" data-sophi-feature=\"interstitial\"><a href=\"https:\/\/www.theglobeandmail.com\/business\/article-ozempic-wegovy-generics-insurance-costs\/\" target=\"_blank\" rel=\"noopener\">Generics of Ozempic and Wegovy expected to lower insurance costs for employers and workers<\/a><\/p>\n<p class=\"c-article-body__text text-pr-5\">Kate Hanna, a spokeswoman for the company\u2019s Canadian branch, told The Globe and Mail on Monday that it is considering competing in the generic market with versions of semaglutide called Plosbrio and Poviztra.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Health Canada approved the new brand names for semaglutide on Dec. 22. Mark Johnson, a spokesman for Health Canada, said the only difference between the old and new versions is in the products\u2019 name and packaging.<\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cTo be clear, these are not generic semaglutide products and have no connection to Health Canada\u2019s review of the generic semaglutide submissions,\u201d Mr. Johnson said by e-mail.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Michael Law, a pharmaceutical policy researcher and academic director of the Centre for Health Policy at the University of Calgary, said this type of product launch is unusual but would give Novo Nordisk new ways of competing for market share when generics come on the market.<\/p>\n<p class=\"c-article-body__text text-pr-5\">The company could maintain Ozempic and Wegovy at their current brand-name pricing, while setting prices for Plosbrio and Poviztra that are close to that of the generics, he said.<\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cThere\u2019s a lot to be captured in the generic market, even at lower prices, because there\u2019s so many people using these drugs and there\u2019ll be even more when it\u2019s cheaper,\u201d Dr. Law said.<\/p>\n<p class=\"c-article-body__text mv-16 l-inset text-pb-8\" data-sophi-feature=\"interstitial\"><a href=\"https:\/\/www.theglobeandmail.com\/business\/commentary\/article-the-transformation-of-risk-in-the-ozempic-era\/\" target=\"_blank\" rel=\"noopener\">Opinion: The transformation of risk in the Ozempic era<\/a><\/p>\n<p class=\"c-article-body__text text-pr-5\">Meanwhile, the head of the generics industry association said that Health Canada\u2019s failure to approve any of the generic semaglutide submissions \u2013 some of which were made nearly two years ago \u2013 means that health plans and patients are paying higher than necessary prices.<\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cThat\u2019s costly to the drug programs,\u201d said Jim Keon, president of the Canadian Generic Pharmaceutical Association. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cIf the price came down by 65 per cent then we think that some patients that aren\u2019t getting the product now could, and could benefit from the diabetes treatment and or the weight-loss treatment.\u201d<\/p>\n<p class=\"c-article-body__text text-pr-5\">Health Canada acknowledged in a statement that there is \u201cconsiderable interest in lowering costs associated with this highly prescribed drug by introducing generic versions,\u201d but said it couldn\u2019t comment on approval timelines while evaluating submissions. <\/p>\n<p class=\"c-article-body__text text-pr-5\">However, the federal regulator noted that the review process for copies of semaglutide is more \u201ccomplex\u201d than for typical generics.<\/p>\n<p class=\"c-article-body__text text-pr-5\">That\u2019s because the original semaglutide is a biologic drug derived from cells. Generic companies are applying to make chemically synthesized copies. \u201cThe manufacturer must show that these differences do not affect the safety, efficacy, or quality of the drug compared to the brand name drug,\u201d Mr. Johnson said.<\/p>\n<p class=\"c-article-body__text mv-16 l-inset text-pb-8\" data-sophi-feature=\"interstitial\"><a href=\"https:\/\/www.theglobeandmail.com\/business\/article-eli-lilly-co-cuts-price-of-popular-diabetes-and-weight-loss-drugs-in\/\" target=\"_blank\" rel=\"noopener\">Eli Lilly &amp; Co. cuts price of popular diabetes and weight-loss drugs in Canada<\/a><\/p>\n<p class=\"c-article-body__text text-pr-5\">Mr. Keon of the CGPA, which represents 17 companies, said the challenge is that Health Canada \u2013 unlike some of its international counterparts \u2013 hasn\u2019t published blanket guidance about what should be included in generic semaglutide applications. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cWe have talked to them about this for quite a while, and they say: \u2018Well, we haven\u2019t got the resources to develop guidances on all these complex products,\u201d Mr. Keon said. The result is that Health Canada asks companies for additional information and clarification after an initial submission is filed, delaying the process, he added. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Ozempic is the top-selling drug by revenue in the country. Nearly $2.15-billion worth of Ozempic was sold at Canadian retail pharmacies between January and September of last year, according to IQVIA Canada, which aggregates prescription sales. Just over $440-million of Wegovy was sold in the same period.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Health Canada\u2019s website lists the names of five companies who have applied to sell generic semaglutide: Apotex Inc., Aspen Pharmacare Canada Inc., Sandoz Canada Inc., Taro Pharmaceuticals Inc. and Teva Canada Ltd. None had updates on their submissions when contacted by The Globe on Monday.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Two other companies applied before April of 2024, when Health Canada updated its policies to identify companies with submissions under review. <\/p>\n<p class=\"c-article-body__text text-pr-5\">One of those is the Indian pharmaceutical company Dr. Reddy\u2019s Laboratories Ltd., which revealed in a regulatory filing in late October that Health Canada <a href=\"https:\/\/www.theglobeandmail.com\/business\/article-dr-reddys-laboratories-health-canada-rejected-application-generic\/\" target=\"_blank\" rel=\"noopener\" title=\"https:\/\/www.theglobeandmail.com\/business\/article-dr-reddys-laboratories-health-canada-rejected-application-generic\/\">had given an initial negative response to its initial application<\/a> and asked for additional information and clarifications. <\/p>\n<p class=\"c-article-body__text text-pr-5\">The second company has not been publicly identified.<\/p>\n","protected":false},"excerpt":{"rendered":"Open this photo in gallery: Health Canada has received nine applications from five named companies to sell duplicates&hellip;\n","protected":false},"author":3,"featured_media":496703,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[25549,210,1060,67,132,68],"class_list":{"0":"post-496702","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-aud-url","9":"tag-health","10":"tag-medication","11":"tag-united-states","12":"tag-unitedstates","13":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115848712412481548","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/496702","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=496702"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/496702\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/496703"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=496702"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=496702"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=496702"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}