Benzinga | Dec 22, 2021 04:55AM EST

Novartis Unit Sandoz Submitted Marketing Authorization Application for Proposed Biosimilar Trastuzumab to EMA

Sandoz, a global leader in generic and biosimilar medicines, today announced that it has submitted a Marketing Authorization Application for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the European Medicines Agency (EMA).

Trastuzumab is a monoclonal antibody used for the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers2. Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical, and clinical data.

"In 2020, breast cancer accounted for 28.7% of all new cancer cases diagnosed, making it the most frequently occurring cancer and first cause of cancer death among women in Europe1", said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. "Biosimilars have enormous potential to improve cancer care. Today's submission is an encouraging step forward in our mission to expand access to advanced biologics treatments to address the evolving needs of patients, healthcare professionals and healthcare systems."

As part of the license agreement signed in April 2019, EirGenix, Inc. 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. On December 20, 2021, Sandoz announced submission of a Biologics License Application for a proposed biosimilar trastuzumab (150 mg) to the US Food and Drug Administration.

Sandoz has been developing and providing oncology medicines for over 30 years. Today, it has more than 50 such medicines, including chemotherapeutics, biologics, hormones and supportive care treatments, for the treatment of a wide range of cancers. The collaboration with EirGenix, Inc. will enable Sandoz to build on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to the sustainability of healthcare systems.