logo
  

Novartis' Sandoz Submits BLA For Proposed Biosimilar Trastuzumab To FDA

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Swiss luxury goods group Compagnie Financiere Richemont AG reported Friday significantly higher profit in fiscal 2022 with strong growth in demand. The company also lifted its dividend, and announced a special dividend. Meanwhile, the shares were losing around 12 percent in the morning trading in Switzerland. Coeurd-Alene, Idaho-based White Cane Smoked Salmon LLC is recalling Wild Alaskan Cooked and Smoked Salmon as it contains undeclared wheat and soy, known allergens, the U.S. Food and Drug Administration said. The affected Alaskan Cooked and Smoked Salmon is packaged in vacuum bag, sold frozen, and there is no lot code or best by date on a package. Auto giant Ford Motor Co. (F) has issued a recall of about 39,000 2021 Expedition and Lincoln Navigator vehicles due to fire risk. The company has asked the customers of the recalled 2021 Ford Expedition and Lincoln Navigator SUVs to park their vehicles outside and away from structures while it investigates...
Follow RTT