Meanwhile, Health Canada has been struggling with a backlog in their pharmaceutical drug review submissions. This unnecessary delay is preventing cheaper biosimilar drugs from entering the market, slowing their launch. This new reality has raised concerns about the ability to access important medications. Patients requiring infusions to treat inflammatory diseases and bone diseases, such as rheumatoid arthritis and osteoporosis, are especially impacted.
Celltrion, a South Korean multinational biopharmaceutical company, sells tocilizumab under the brand name Avtozma. This powerful medication is routinely prescribed to manage a range of chronic inflammatory illnesses, from asthma and psoriasis to rheumatoid arthritis. Celltrion went on to file three products with the FDA for approval already in 2024, now several months overdue. These delays damage the immense public unclaimed company goodwill dependent on launching the company’s product. For one, they reduce patients’ access to lower-cost treatment alternatives.
Following a move to the new regulatory framework, Health Canada is dealing with a historic backlog of submissions. This delay prevents people from accessing less expensive versions of their highest cost biologic drugs. In 2023, biosimilars accounted for almost 30 per cent of all public drug spending in Canada. This large share underscores their importance to the nation’s healthcare delivery system. As the need for these high demand medications continues to rise, approval through our drug shortage pipeline becomes even more essential.
British Columbia has taken considerable, commendable steps to establish biosimilars within its healthcare system. In 2019, it became the first state in the country to implement a biosimilar switching plan. Over 69,000 patients have made the switch to newer, often equally effective biosimilar therapies since then, saving the province over $400 million. The SAVE BC initiative has saved British Columbia’s public drug plan about $732 million over 5 years.
Celltrion’s two newest submissions comprise denosumab products, a new class of bone-building drugs. Stoboclo is a biosimilar version of Prolia, and it targets osteoporosis. Meanwhile, Osenvelt has a higher-dose formulation of denosumab in the works, specifically, an oncology formulation. Sales of biologic drugs in Canada increased to over $15 billion per year as of 2023. This is a huge jump up from a mere $4.9 billion in 2014. This trend highlights the increasing importance of biologic therapies in the Canadian health care system.
Jim Keon, a representative from the pharmaceutical industry, expressed concerns regarding the investment landscape in Canada due to these delays.
“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,” – Jim Keon.
Health Canada has recognized the key problem and have been actively working to address the pharmaceutical submissions backlog. Stakeholders are cautiously optimistic that the federal government’s measures to speed up drug approval timelines will prove fruitful.
“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.
The B.C. Ministry of Health remains focused on reducing pharmaceutical costs as part of its broader commitment to ensuring a sustainable healthcare system.
“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,” – The B.C. Ministry of Health.
