July 21, 2016
Amgen and Allergan plc have announced results from a Phase 3 study that evaluates safety and efficacy of ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. Based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR), the results ruled out inferiority compared to trastuzumab but could not rule out superiority. The primary endpoint had a pre-specified equivalence margin of +/- 13 percent and the observed upper end of the confidence interval was 13.4 percent.
As said by Sean E. Harper, M.D., executive vice president of Research and Development at Amgen: “We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to continued discussions with regulatory authorities. Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we’ve generated supports ABP 980 as highly similar to the reference product.”
“These results provide significant clinical evidence that ABP 980 could be an important biosimilar treatment option for patients with HER2-positive early breast cancer. Allergan is committed to the continued development of ABP 980 and other biosimilars that provide safe, high-quality and effective therapies in key disease areas,” said David Nicholson, chief research and development officer, Allergan.