At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab).
First, Amgen presented Phase 3 study data on ABP980, which it is co-developing with Allergan plc, comparing the safety and efficacy of ABP 980 to Herceptin in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. Amgen reported that the efficacy, safety, and immunogenicity data supports ABP 980 as a trastuzumab biosimilar.
Second, Pfizer presented Phase 3 study data on PF-05280014, its investigational trastuzumab biosimilar. Pfizer’s Phase 3 REFLECTIONS B327-02 study found no clinically meaningful differences between PF-05280014 and Herceptin in terms of efficacy, safety, immunogenicity, and noninferiority in pharmacokinetics in patients with HER2-positive breast cancer.
As we previously reported, other companies are engaged in Phase 3 clinical development of proposed biosimilars of Herceptin, including Samsung Bioepis (SB3), Mylan/Biocon (MYL-1401O) and Celltrion (CT-P6), the latter two of which have already submitted aBLAs to the FDA (as reported here and here).