The South Korea headquarters of Celltrion, a global drugmaker with offices in Canada. Celltrion submitted three products for approval to Health Canada in 2024 that are now overdue.Kim Hong-Ji/Reuters
Health Canada says it is working to reduce a backlog of pharmaceutical submissions that is causing a delay in cheaper versions of high-cost biologic drugs coming to market.
The pledge to speed up the reviews of the biosimilar class of drugs is part of a wider effort by the department to reduce red tape, which Health Minister Marjorie Michel has called a priority for the federal government.
Biosimilars are cheaper near copies of biologic drugs. Biologics are medications produced from living cells or organisms, unlike traditional pills synthesized from chemicals.
Insulin is a well-known biologic, as are Remicade and Humira, the brand names of some of the top-selling drugs for autoimmune diseases. Biosimilars are less expensive than the brand-name drugs they mimic, although prices vary by product.
The Globe and Mail has previously reported that Health Canada hit its 180-day deadline for reviewing generic-drug submissions 84 per cent of the time in the most recent fiscal year, down from 100 per cent just three years ago. But most of those on-time responses were last-minute rejections with requests for more paperwork. And nearly all the drugs were ultimately approved after going through any additional paperwork.
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Detailed statistics were not available for biosimilar drugs, which have a review target of 300 days.
But Health Canada acknowledged it has a large backlog of submissions for biosimilars, which it said was because of the number of biosimilar submissions increasing more than 400 per cent from 2016 to 2025, while department “resources” remained “relatively constant.”
Celltrion, a global drugmaker based in South Korea with offices in Canada, has three products that were submitted in 2024 that are now months overdue. Two are types of a drug called denosumab, which treat bone-related issues. (Stoboclo, the biosimilar version of Prolia, is used to treat osteoporosis, while the higher-dose form Osenvelt is used in cancer treatment.) Both drugs were submitted to Health Canada in May of 2024, according to public records.
The third drug is tocilizumab (which Celltrion sells under the name Avtozma), which is used to treat various forms of inflammation, including rheumatoid arthritis. It was submitted in July of 2024.
Matthew Sarabura, national payer manager at Celltrion, said the company expected to have all three drugs ready for patients this June. It had even hired health care professionals to work in a patient-support program, which is on hold until the drugs are approved.
Jim Keon, president of industry group Biosimilars Canada, said the delays are threatening the financial viability of these products.
“Absent some kind of certainty around the marketplace, companies will simply not see Canada as an attractive place to invest, and that’s why we’re concerned,” he said.
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Even beyond the effect on drugmakers, the delays could also lead to higher costs for health insurance plans.
The pan-Canadian Pharmaceutical Alliance, which negotiates drug prices on behalf of federal, provincial and territorial drug plans, hammers out pricing deals for each new biosimilar approved by Health Canada.
When Health Canada falls behind on approving new biosimilars, payers may have to keep shelling out for more expensive, original biologics.
Sales of biologic drugs in Canada have soared in recent years. They reached $15-billion annually in 2023, up from $4.9-billion in 2014, according to the research arm of the Patented Medicines Prices Review Board, Canada’s drug-pricing regulator.
The category accounted for nearly 30 per cent of total public drug spending in Canada in 2023, the most recent year for which the Canadian Institute for Health Information has published data.
In a bid to save taxpayer dollars, every province and territory but Nunavut has enacted mandatory switching policies that force patients to take cheaper biosimilars if they want their medications publicly covered.
British Columbia implemented the country’s first biosimilar switching plan in 2019. Since then, just more than 69,000 patients have switched to a biosimilar, saving the provincial drug plan $732-million over five years.
“We are encouraged by the federal government’s commitment to speed up drug approval timelines. Any time we can improve efficiency in the system and get people timely access to the medications they need, at affordable prices, and without compromising patient safety – that is a good thing,” the B.C. Ministry of Health said in a statement.
“In B.C., we remain focused on reducing pharmaceutical costs to ensure people have a sustainable health care system now and in the future, and our biosimilar initiative continues to do just that.”
Health Canada said it plans to meet with biosimilar makers later in September to “engage in discussions on the situation with the backlog of submissions, offering an opportunity to share ideas to reduce administrative burden for industry and improve transparency of the review process.”