Amgen, Allergan report Phase III data for Herceptin biosimilar

Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) said data from a Phase III study showed ABP 980, a biosimilar of Herceptin trastuzumab, was non-inferior to its reference product based on the proportion of patients with a pathologic complete response (pCR), the primary efficacy endpoint. The double-blind study enrolled 725 women with HER2-positive early breast cancer, and contained a neoadjuvant and adjuvant phase.

The companies said the data "could not rule out superiority" of ABP 980 vs. Herceptin based on the endpoint, which had a prespecified equivalence margin of 13%. According to Amgen and Allergan, the upper end of the confidence interval was 13.4% on the endpoint. ...