=Amgen (AMGN) and Allergan (AGN) announced data from a Phase 3 study

Amgen and Allergan (AGN) present Phase 3 data between ABP 980 and Trastuzumab adds to the totality of evidence of biosimilarity 

• Amgen (AMGN) and Allergan plc (AGN) announced data from a Phase 3 study evaluating the efficacy and safety of ABP 980, a Herceptin (trastuzumab) biosimilar, compared with the originator product in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer.
• The co-primary endpoints of the study were risk difference and risk ratio of pathologic complete response in breast tissue and axillary lymph nodes, and the prespecified equivalence margins were +/-13% for RD and 0.759 to 1.318 for RR. According to local review, 48% and 40.5% of patients in the ABP 980 arm and trastuzumab arm, respectively, achieved pathologic complete response.
  • RD and RR of pathologic complete response were 7.3% (90% CI: 1.2, 13.4) and 1.19 (90% CI: 1.033, 1.366) respectively. Based on central independent review, which was conducted as part of a sensitivity analysis, 47.8% and 41.8% in the ABP 980 arm and trastuzumab arm, respectively, achieved pathologic complete response.
  • RD and RR of pathologic complete response respectively were 5.8% (90% CI: -0.5, 12.0) and 1.14 (90% CI: 0.993, 1.312).
• Frequency, type and severity of adverse events were similar between ABP 980 and trastuzumab. No new safety signals compared to the known safety profile of trastuzumab were detected