Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab), to the Food and Drug Administration (“FDA”).  According to the press release, Amgen and Allegan have “formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines.”

Celltrion and Teva also announced last week that the FDA has accepted their BLA for CT-P6, a proposed trastuzumab biosimilar, for review.  According to the announcement, the companies expect regulatory action on the CT-P6 application during the first half of 2018.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

Several other companies, including at least Pfizer (Hospira), Mylan, and Biocon are also developing biosimilars of trastuzumab, as discussed in this prior post.  A complete list of IPRs related to trastuzumab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.