Amgen (AMGN) and Allergan plc (AGN) announced results from a Phase 3 study evaluating efficacy and safety of ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive early breast cancer. The company said the results ruled out inferiority compared to trastuzumab but could not rule out superiority based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response. ABP 980 is being developed as a biosimilar to trastuzumab. Overall, adverse events were comparable between ABP 980 and trastuzumab.
Sean Harper, executive vice president of Research and Development at Amgen, said: "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."
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars.
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