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# Amgen, Allergan Report Positive Data on Herceptin Biosimilar
- URL: https://www.fdaweb.com/amgen-allergan-report-positive-data-on-herceptin-biosimilar/
- Published: 2016-07-21T12:00:00.000Z
- Updated: 2026-09-14T21:16:18.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136248

Amgen and Allergan have announced results from a Phase 3 study evaluating the efficacy and safety of their biosimilar candidate ABP 980 compared with Genentech’s Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. “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 (pCR),” the companies say. “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.” Trastuzumab is approved for treating HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer.

Observed adverse events were comparable between ABP 980 and trastuzumab, the companies say. “In the neoadjuvant phase of the study, which included chemotherapy, there were more serious adverse events reported in the ABP 980 group, the majority of which were reported by the investigators as unlikely related to investigational product,” they add. “In the adjuvant phase of the study, which did not include chemotherapy, serious adverse events were comparable between treatment groups. The overall results also showed comparable immunogenicity.