Novartis' Sandoz Submits BLA For Proposed Biosimilar Trastuzumab To FDA

(RTTNews) - Novartis AG's (NVS) unit Sandoz announced the submission of its Biologics License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix Inc. to the US Food and Drug Administration.

Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers.

As part of the license agreement signed in April 2019, EirGenix is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.