theglobeandmail.com
Health Canada vows to expedite biosimilar drug approvals to reduce costs
Health Canada is addressing a backlog in biosimilar drug approvals, aiming to accelerate the market entry of cheaper alternatives to costly biologic drugs, driven by a 400 percent surge in submissions since 2016 and a need to reduce costs for public drug plans.
- How are these delays impacting drugmakers and healthcare payers?
- Delays threaten the financial viability of biosimilar drugmakers, potentially deterring future investments in Canada. Simultaneously, the delays force public drug plans to continue paying for more expensive brand-name biologics, increasing healthcare costs. The pan-Canadian Pharmaceutical Alliance, which negotiates drug prices, is impacted by the delayed approvals.
- What is the primary cause of the delay in cheaper biosimilar drugs reaching the Canadian market?
- A significant backlog of biosimilar drug submissions at Health Canada, stemming from a more than 400 percent increase in submissions between 2016 and 2025, while departmental resources remained relatively constant, is causing delays. This backlog prevents the timely approval of cheaper alternatives to high-cost biologic drugs.
- What are the potential long-term consequences of these delays, and what measures are being taken to address them?
- Continued delays could hinder Canada's ability to control rising drug costs, especially considering the increasing reliance on biologic drugs. Health Canada plans to meet with biosimilar manufacturers to discuss the backlog and find ways to streamline the approval process, aiming to improve transparency and reduce administrative burdens.
Cognitive Concepts
Framing Bias
The article presents a balanced view of the situation, presenting both the government's commitment to expedite the review process and the concerns of drugmakers and industry groups regarding delays. The inclusion of various perspectives, including that of Health Canada, drug manufacturers (Celltrion), industry groups (Biosimilars Canada), and provincial governments (British Columbia), prevents a one-sided narrative. However, the article's focus on the significant cost savings from biosimilars might subtly frame the issue as one of economic efficiency rather than solely patient care.
Language Bias
The language used is largely neutral and objective. Terms like "cheaper near copies" and "less expensive" accurately describe biosimilars without resorting to overly positive or negative connotations. The use of quotes from various stakeholders further enhances neutrality. However, phrases like "soared" to describe the increase in biologic drug sales might carry a slightly negative connotation, suggesting an unsustainable trend.
Bias by Omission
While the article provides a comprehensive overview, it could benefit from including data on the specific reasons for delays in the approval process. Providing more details on the types of administrative hurdles or complexities in biosimilar reviews would offer a more complete picture. Additionally, the article could mention potential negative impacts on patients due to delays, beyond the financial aspects discussed.
Sustainable Development Goals
The article focuses on Health Canada's efforts to reduce delays in approving biosimilar drugs. Faster approvals mean quicker access to more affordable medications for patients, improving health outcomes and reducing healthcare costs. This directly contributes to SDG 3, which aims to ensure healthy lives and promote well-being for all at all ages. The mentioned biosimilars treat various conditions like osteoporosis, cancer, and rheumatoid arthritis, making timely access crucial for patient well-being. The success of biosimilar switching policies in British Columbia, saving millions and improving access, further strengthens this connection.