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Late-stage study shows biosimilar candidate ABP 980 non-inferior to Roche's Herceptin

Jul. 21, 2016 9:46 AM ETAmgen Inc. (AMGN) StockAMGN, RHHBY, AGNBy: Douglas W. House, SA News Editor
  • Results from a randomized 725-subject Phase 3 study assessing the safety and efficacy of Amgen (AMGN +0.4%) and collaboration partner Allergan's (AGN +0.5%) biosimilar candidate ABP 980 compared with Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) demonstrated ABP 980's non-inferiority (no worse than) to the branded product. The data failed to show, however, that Herceptin was not superior to ABP 980 as measured by the primary endpoint of the difference in the percentage of patients with a pathologic complete response. The prespecified equivalence margin was plus/minus 13% and the observed upper end of the confidence interval was slightly higher at 13.4%. Adverse events were comparable.
  • Despite the modest miss, the companies believe the data will be sufficient for regulatory approval.
  • Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars under an agreement inked in December 2011 between Amgen and Watson Pharmaceuticals. Under the terms of the partnership, Amgen has primary responsibility for development, manufacturing and initial commercialization.

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