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FDA Approves First Biosimilar for Cancer Treatment

Jason Harris
Published: Thursday, Sep 14, 2017

The FDA announced today that, for the first time, it has approved a biosimilar for the treatment of cancer.

Overall response rate was 39% in the ABP-215 arm compared with 41.7% for EU-bevacizumab (risk ratio, 0.93; 90% CI, 0.8-1.09). There were 2 complete responses in each group, and 38.4% of the ABP-215 group had partial responses versus 41.1% in the bevacizumab group. Duration of response was 5.8 months for ABP-215 (95% CI, 4.9-7.7) compared with 5.6 months with bevacizumab (95% CI, 5.1-6.3).


Forty percent of patients in both groups experienced progression-free survival (PFS) events (HR, 1.03; 95% CI, 0.8-1.34). Median PFS was 6.6 months for ABP-215 (95% CI, 6.3-7.9) versus 7.0 months in the bevacizumab arm (95% CI, 6.6-8.2).

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