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Sandoz Submits Biosimilar Trastuzumab Applications to FDA and EMA to Challenge Roche's Herceptin

Dec 25, 2021 00:39 CST Updated 00:39
Sandoz

Global Supplier of Novel Patent Medicines

Roche

Oncology Drug Research, Development, and Manufacturing

FDA

U.S. Food and Drug Administration

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.


News / BIOON / -- Sandoz, the generics division of Novartis, recently announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its trastuzumab biosimilar (150mg, intravenous use). This trastuzumab biosimilar was developed by EirGenix and is a biosimilar to Roche's branded drug Herceptin (trastuzumab).

Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer and metastatic gastric cancer. Sandoz is seeking approval for its trastuzumab biosimilar to have the same indications as the reference drug, Herceptin (trastuzumab). In the United States and the European Union, the marketing application for this trastuzumab biosimilar is based on a comprehensive data package, including analytical, preclinical, and clinical data.

As part of the licensing agreement signed in April 2019, EirGenix will be responsible for the development and manufacturing, and Sandoz has the right to commercialize the drug in all markets except mainland China and Taiwan after obtaining approval.

Florian Bieber, Global Head of Biopharmaceutical Development at Sandoz, stated: "Approximately 15-20% of breast cancer patients have HER2-positive tumors, which tend to grow faster than HER2-negative ones.Tumor"Quick, rapid treatment can save lives. Trastuzumab is the standard therapy for HER2-positive breast cancer, so if approved, we will introduce more competition, aiming to expand the use of this important therapy and release medical resources that can be used to fund other innovative drugs."(Bioon.com)