Health Canada Backlog Delays Generic Ozempic Arrival, Sparking Concerns Over Drug Access
OTTAWA – Canadians seeking more affordable access to semaglutide, the active ingredient in popular drugs like Ozempic and Wegovy, face further delays as a notable backlog at Health Canada is expected to postpone the approval of generic versions. The agency has indicated it will prioritize semaglutide submissions due to the drug’s high demand and to ensure a consistent supply, but the process remains stalled for some manufacturers.
More than a million Canadians currently use a semaglutide drug, according to Novo nordisk, the maker of Ozempic. However,the approval of lower-cost generic alternatives is being hampered by lengthy review times.
dr. Reddy’s laboratories Ltd., which submitted its application to Health Canada in February or March of last year, recently received a notice of non-compliance, signaling further questions from the agency regarding its submission.
The delays come as Prime Minister Justin Trudeau‘s election platform, announced in April, pledged to accelerate drug approvals in Canada, which currently lag behind other developed nations. A recent report highlighted that Canadians can wait years for drugs already approved elsewhere.
Health Minister Marjorie Michel’s office acknowledged the issue, stating they are “working on the issue and see the importance of cutting red tape to get treatments to patients sooner and create a more attractive habitat for businesses.” Spokesperson Guillaume Bertrand added, “The approval process currently takes too long, with bureaucracy getting in the way of delivering essential medications to Canadians who need them.”
Health Canada stated that it is modernizing drug-approval regulations, but complex submissions naturally require more time.
Despite the commitment to faster approvals, the recently tabled federal budget did not allocate new resources to address the backlog. The Canadian Generic Pharmaceutical Association (CGPA) expressed disappointment, noting that over 500 generic submissions are currently under review, with more than 100 backlogged.
“every day of delay in approving these medicines costs the health care system millions and denies drug plans the savings needed to fund new treatments, which is not in the interests of Canadian taxpayers, employers, and patients,” said CGPA president Jim Keon in a statement released in November. The CGPA also pointed out that the review process is largely funded by industry fees.
