Phase III study confirms similarity of Herceptin biosimilar from Amgen, Allergan
pharmafile | July 22, 2016 | News story | Medical Communications, Research and Development | Allergan, Amgen, Herceptin, Roche, biosimilar, trastuzumab
Amgen and Allergan have announced the results from a Phase III study investigating ABP 980, their biosimilar candidate for Roche’s Herceptin (trastuzumab), which ruled out inferiority against the originator in HER2-positive early breast cancer.
The pair have collaborated on the development and commercialisation of four oncology biosimilars. In the case of the proposed Herceptin biosimilar, this Phase III study ruled out inferiority but could not definitively show superiority based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response.
This primary endpoint had a prespecified equivalence margin of +/- 13% and the observed upper end of the confidence interval was 13.4%.
While adverse events were broadly similar between ABP 980 and Herceptin, the ABP 980 arm plus chemotherapy reported more serious adverse events. According to the investigators, these events were unlikely to be related to the product.
Sean Harper, executive VP of R&D at Amgen, says: “We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to discussion 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.”
David Nicholson, chief R&D officer at Allergan, adds: “These results provide significant clinical evidence that ABP 980 could be an important biosimilar treatment option for patients with HER2-positive early breast cancer.”
Sean Murray
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