British Columbia’s Biosimilar Policy Shows No Impact on Hospital Visits

A health policy in British Columbia that required biosimilar prescriptions showed no increase in hospital visits or complications, according to real-world evidence that etanercept biosimilars for inflammatory arthritis are as effective as their originator biologics without increasing hospital utilization.1

This study was conducted to address the gap between clinical trial data and real-world outcomes for biosimilars, particularly among patients newly initiating treatment for inflammatory arthritis. While randomized controlled trials have established the efficacy and safety of etanercept biosimilars under ideal conditions, there remains limited evidence on how these therapies perform in routine clinical practice.

In 2017, British Columbia introduced a policy requiring that new prescriptions for certain biologic drugs be filled with biosimilars to qualify for coverage under the public drug plan.2 The program was rolled out in several phases and has since been replicated to some extent in nearly every other Canadian province due to the success seen in BC.3,4 This mandate, which has already accumulated $732 million in savings in the first 5 years for the province,5 created a “natural experiment” for the researchers, who used it to evaluate health care utilization as an indicator of biosimilar safety and effectiveness in real-world settings.1

“Lack of confidence in biosimilars' effectiveness, safety and interchangeability has been identified as one of the top barriers impairing the adoption of biosimilar therapies…Our findings on no unintended consequences of policy change at the health system level inform decisions in biosimilar policy development and implementation in other jurisdictions,” wrote the researchers.

The authors of the retrospective cohort study assessed the impact of British Columbia’s policy by applying a regression discontinuity design to real-world administrative health data from 2014 to 2023. Researchers identified adult patients diagnosed with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who were newly prescribed etanercept. Patients were grouped based on whether they started treatment just before or just after the policy took effect, allowing for a natural comparison.

Outcomes such as hospitalizations, emergency department visits, and physician encounters were tracked for three years. Both intention-to-treat and instrumental variable analyses were conducted to evaluate health care utilization, accounting for both policy exposure and actual biosimilar uptake.

Researchers analyzed outcomes among 1626 incident users in the pre-policy period (2014-2017) and 1378 in the post-policy period (2017-2020). Demographics were similar across groups (mean age at diagnosis, 52.5 years; 63.7% female). Biosimilar initiation rose from just 0.06% pre-policy to 78.3% post-policy. Despite this sharp uptake, no significant changes in healthcare utilization were observed.

For all-cause hospitalizations (ACH), intention-to-treat (ITT) analysis yielded unadjusted and adjusted rate ratios at the policy cut-off of 0.97 (95% CI, 0.55-1.69) and 0.84 (95% CI, 0.49-1.44), respectively. Complier average causal effect (CACE) analysis showed similarly neutral effects with ratios of 0.97 (95% CI, 0.53-1.75) and 1.01 (95% CI, 0.53-1.92). Infection-related hospitalizations (IRH) were rare, and both ITT and CACE analyses showed wide confidence intervals with no statistically significant impact: the adjusted CACE ratio was 0.89 (95% CI, 0.03-23.35).

No meaningful differences were observed for emergency room visits (ERV) or hospital length of stay (LOS). For example, adjusted ITT rate ratios for LOS and ERV were 0.94 (95% CI, 0.41-2.15) and 0.91 (95% CI, 0.44-1.88), respectively. Sensitivity analyses using alternative statistical methods and bandwidths confirmed the robustness of findings. Analysis of adalimumab initiators, which were unaffected by biosimilar policy, showed no concurrent changes in health care use, supporting the specificity of the results.

“The equivalent real-world effectiveness and safety of etanercept biosimilars shown in this study will increase healthcare providers' and patients' confidence in prescribing and taking this important medication,” the authors expressed.

References

1. Zhou VY, Lacaille D, Zheng Y, et al. The impact of biosimilar use on healthcare utilization among new users of etanercept for inflammatory arthritis: a population-based regression discontinuity analysis. Lancet Reg Health Am. Published online April 11, 2025. doi:10.1016/j.lana.2025.101058

2. Davio K. British Columbia becomes the first Canadian province to mandate a switch to biosimilars. The Center for Biosimilars®. May 28, 2019. Accessed June 17, 2024. https://www.centerforbiosimilars.com/view/british-columbia-becomes-the-first-canadian-province-to-mandate-a-switch-to-biosimilars

3. Hagen T. British Columbia moves into third phase of mandatory switching. The Center for Biosimilars. August 25, 2020. Accessed May 27, 2025. https://www.centerforbiosimilars.com/view/british-columbia-moves-into-third-phase-of-mandatory-switching

4. Jeremias S. Manitoba adopts biosimilar switching policy. The Center for Biosimilars. August 7, 2024. Accessed May 27, 2025. https://www.centerforbiosimilars.com/view/manitoba-adopts-biosimilar-switching-policy

5. Jeremias S. British Columbia’s biosimilar switching program saves $732 million in 5 years. The Center for Biosimilars. June 18, 2024. May 27, 2025. https://www.centerforbiosimilars.com/view/british-columbia-s-biosimilar-switching-program-saves-732-million-in-5-years