• Biologics License Application (BLA) is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix, Inc.   
  • Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers1,2
  • Sandoz continues to build on leading generic and biosimilar oncology portfolio to increase patient access and contribute to sustainability of healthcare systems

BASEL, Switzerland I December 20, 2021 I Sandoz, a global leader in generic and biosimilar medicines, today 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 (FDA).

Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers1. Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical and clinical data.

“Approximately 15-20% of all breast cancer patients have tumors that are HER2- positive2 and, as these tumors tend to grow more quickly than HER2-negative tumors,3 getting treated swiftly can be live-saving,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. “Trastuzumab is standard of care so, if approved, we will introduce more competition aiming to broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines in the US.”

Breast cancer is the most commonly diagnosed cancer among women in the US and associated death rates are the second highest of all cancers. It is estimated that about 30% of newly diagnosed cancers in women will be breast cancers in 20214.

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.

Sandoz has been developing and providing oncology medicines for over 30 years. Today, it has well over 50 such medicines, including chemotherapeutics, biologics, hormones and supportive care treatments, for the treatment of a wide range of cancers. The collaboration with EirGenix 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.

About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

Sandoz on social media:
LinkedIn: https://www.linkedin.com/company/sandoz
Twitter: https://twitter.com/sandoz_global
Facebook: https://www.facebook.com/sandozglobal/
Instagram: https://www.instagram.com/sandozglobal

CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/


  1. US FDA. Herceptin® (trastuzumab). Highlights of prescribing information. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf [Last accessed October 2021].
  2. Kowalczyk L, Bartsch R, Singer CF, Farr A. Adverse events of trastuzumab emtansine (T-DM1) in the treatment of HER-2 positive breast cancer patients. Breast Cancer (Basel) 2017;12(6):401–408.
  3. Dean L. Trastuzumab (Herceptin) Therapy and ERBB2 (HER2) Genotype. In: Pratt V, McLeod H, Rubinstein W, et al. (Eds). Medical Genetics Summaries [online]. 5 August 2015. Bethesda (MD): National Center for Biotechnology Information (US). Available from: https://www.ncbi.nlm.nih.gov/books/NBK310376/ [Last accessed: October 2021].
  4. Breastcancer.org. U.S. Breast Cancer Statistics. Available from: https://www.breastcancer.org/symptoms/understand_bc/statistics [Last accessed: October 2021].

SOURCE: Sandoz