Current status and trends of anti-tumor biosimilars in China from 2019 to 2023: A cross-sectional analysis

While several anti-tumor biosimilars have been approved in China, comprehensive nationwide analyses of their real-world utilization patterns remain limited, particularly regarding cross-regional adoption and indication-specific usage. We collected information on patients treated with bevacizumab, rituximab, trastuzumab and their biosimilars at 109 hospitals in nine Chinese cities from 2019 to 2023. Analysis of 264,527 prescriptions revealed rapid biosimilar adoption for bevacizumab (2023 originator share: 20.0%, -25.1%/year), moderate for rituximab (32.1%, -16.8%/year), and limited for trastuzumab (70.0%, -8.3%/year). Geographic variation was substantial (2023 city ranges: bevacizumab 2.3-43.0%; rituximab 6.7-70.3%; trastuzumab 42.4-92.4%). Tertiary hospitals showed faster biosimilar uptake than secondary hospitals (bevacizumab: + 23.7%). Free medical care patients preferred originators (bevacizumab: 64.1% vs 38-39% for other payers). Off-label use demonstrated significantly higher biosimilar adoption (bevacizumab: 69.0%; rituximab: 52.1%) versus approved indications (p < 0.00625). Cost distributions mirrored prescription trends but consistently favored originators. All trends were statistically significant (p < 0.05). The biosimilar market share showed steady annual growth, however the growth rates vary across different products. However, Patients with lower out-of-pocket costs remained more likely to choose original products. Enhanced regulatory oversight of both approved and off-label/extrapolated indications is needed to ensure appropriate biosimilar utilization.