FDA investigators find no safety risks when switching between biologics, biosimilars
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Key Takeaways:
- The meta-analysis included data from 31 studies with 44 distinct switch treatment periods.
- The risk for death, serious adverse events and treatment discontinuation did not change when patients switched to a biosimilar.
Switching between biosimilars and reference products did not increase the risk for death or serious adverse events, according to a meta-analysis conducted by FDA investigators.
“Increasing the availability and use of biosimilars is an important public health strategy for reducing drug costs and increasing the availability of biological products to underserved populations,” Thomas M. Herndon, MD, of the FDA’s Office of Therapeutic Biologics and Biosimilars, and colleagues wrote in PLS One. “Despite the adoption of biosimilars in many therapeutic areas, concerns persist regarding switching a patient to a biosimilar whose condition is stable while on the reference biologic. Among health care stakeholders, these concerns are more prevalent among prescribers and, as a result, their patients.”
To examine safety outcomes among patients who switch to a biosimilar after achieving stable condition with a biologic, Herdon and colleagues conducted a systematic review and meta-analysis. The researchers analyzed clinical studies in FDA databases from Jan. 1, 2000, to Dec. 31, 2022, that were submitted in a biologics license application for biosimilars. Studies had to include a switch treatment period between the biosimilar and its reference biologic, and they had to include safety data. In all, the researchers investigated 31 studies with 44 distinct switch treatment periods.
According to the researchers, the risks for death, serious adverse events and treatment discontinuation were the same among patients who switched and those who did not. There were 21 deaths out of 5,252 participants who switched and 23 deaths out of 5,770 who did not, making the risk difference –0 (95% CI, –0 to 0). The risk difference for serious adverse events was –0 (95% CI, –0.1 to 0.1), and the risk difference for treatment discontinuation was –0 (95% CI, –0.1 to 0).
“The findings reported here support reducing the regulatory burden of switching studies as the default approach for addressing the switching standard for the interchangeable designation,” Herndon and colleagues wrote. “This work also supports reassessing the need for switches included in clinical studies for candidate biosimilars as an approved biosimilar will be analytically highly similar to its reference product.”
Reference:
Safety outcomes when “switching” between biosimilars and reference products. https://www.fda.gov/drugs/news-events-human-drugs/safety-outcomes-when-switching-between-biosimilars-and-reference-products. Published Dec. 5, 2023. Accessed Dec. 19, 2023.
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Herndon TM, et al. PLoS One. 2023:doi:10.1371/journal.pone.0292231.
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