Sandoz Submits BLA for Proposed Biosimilar Trastuzumab to the FDA

Last week, Sandoz announced that it submitted a Biologic License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) to the FDA.  According to the press release, the biosimilar trastuzumab was developed by EirGenix, Inc. pursuant to a 2019 license agreement that gives Sandoz the right to commercialize the biosimilar upon approval in all markets excluding China and Taiwan.

Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers.  Sandoz is seeking approval for the same indications as the reference product, Genentech’s HERCEPTIN, based on a comprehensive package that includes analytical, preclinical and clinical data.