Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

Biosimilar News

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).

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