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.”
Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019)
The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public meeting on Wednesday, July 12, 2017, to consider Novartis’ biologic license application (BLA 125646) for tisagenlecleucel (CTL019), an investigational chimeric antigen receptor T cell (“CAR-T”) therapy. Novartis is seeking approval of CTL019 for the treatment of patients from
The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215, Amgen’s proposed biosimilar to Genentech’s Avastin (bevacizumab), on July 13, 2017. According to the announcement, the proposed indications and uses for ABP 215 include: