Health Canada is currently assessing nine submissions for generic versions of well-known weight loss medications, a move that experts believe could lead to reduced prices for consumers. These submissions in Canada pertain to generic forms of semaglutide, the key component in Novo Nordisk’s injectable drugs Ozempic and Wegovy, which have been endorsed by Health Canada for treating diabetes and aiding weight loss.
Semaglutide falls under the class of glucagon-like peptide-1 (GLP-1) therapies, which imitate a natural gut hormone to regulate blood sugar levels, slow down digestion, and enhance the feeling of fullness. Potential side effects of semaglutide include nausea, vomiting, diarrhea, stomach pain, fatigue, constipation, and headaches.
Canada is unique as the only country where Novo Nordisk’s patent for semaglutide drugs has expired, allowing for the expiration of “regulatory exclusivity” on January 4. Consequently, Canada may potentially be the first nation to offer a more economical version of Ozempic and Wegovy to patients with prescriptions, although immediate availability is unlikely, according to pharmaceutical experts.
Novo Nordisk has introduced a pill form of Wegovy in the U.S., with plans to release higher doses by the week’s end. While inquiries regarding the availability of the Wegovy pill in Canada were redirected to Novo Nordisk’s U.S. media release, Health Canada has not confirmed the receipt of an application for the Wegovy pill or a generic pill version from Novo Nordisk.
Generics, as per Health Canada, are essentially identical to brand name drugs and undergo rigorous evaluation to ensure safety, quality, and effectiveness. Assessing generic semaglutide drugs is particularly intricate due to the drug’s initial biological development, contrasting with simpler chemical methods utilized in generic manufacturing.
Factors influencing pricing include the drug’s availability in branded form, the number of generic alternatives on the market, the drug’s formulation (oral or injectable), and dosing. Given these complexities, the approval and availability of cheaper versions are not expected immediately, with a possible timeline extending to the summer.
The potential approval of generic versions could significantly lower costs for Canadians using GLP-1 medications for weight loss, currently paying between $200 to $400 monthly out of pocket due to limited insurance coverage. The accessibility and affordability of these medications are crucial for managing obesity, a condition affecting a substantial portion of the Canadian population.
Noteworthy companies seeking generic submissions review from Health Canada include Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals, and Aspen Pharmacare Canada. Other applicants remain undisclosed due to a policy change by Health Canada in April 2023 mandating the disclosure of sponsor names.