EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

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The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

On Sept. 18, 2023, Sandoz announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has given a positive opinion on the company’s biosimilar trastuzumab (150 mg, for intravenous use), a monoclonal antibody for treating human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, the same indications for which the reference biologic is approved in Europe. The biosimilar trastuzumab was developed by EirGenix, a Taiwan-based biopharmaceutical company.

Under an April 2019 licensing agreement (1), EirGenix will maintain responsibility for the development and manufacturing of the biosimilar trastuzumab, while Sandoz holds the rights to commercialize the product once approval is gained in respective markets.

Breast and gastric cancers have significant impact in Europe, with more than 355,000 women each year diagnosed with breast cancer. With 92,000 deaths per year, breast cancer is the number one cause of cancer death among women, according to a company press release. Gastric cancer, meanwhile, is the sixth most common cancer type and ranks the fourth most common cause of cancer-related deaths in Europe, with 107,000 deaths annually, according to the release. HER2 protein overexpression (or HER2 gene amplification) is detected in up to 20% of breast cancers and up to 30% of gastric cancers that are diagnosed. The overexpression of this protein leads to uncontrolled growth and division of cells, and HER2 cancers are known to be particularly aggressive cancer types that respond well to targeted treatment, according to the press release.

The regulatory submission package for Sandoz’ biosimilar trastuzumab comprised comprehensive analytical, preclinical, and clinical data and included evidence that was derived from extensive analytical characterization. Data also included results from a Phase I pharmacokinetic/pharmacodynamic study and a confirmatory Phase III study. The results showed that both studies met their respective primary endpoints, which confirms that the biosimilar matches the reference biologic in terms of both pharmacokinetics and efficacy, safety, and immunogenicity.

“Breast and gastric cancers are among the most frequently occurring in Europe and, combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines,” said Pierre Bourdage, chief commercial officer, Sandoz, in the release.



1. EirGenix, Eirgenix Signs Trastuzumab Biosimilar License Agreement with Novartis Sandoz. Press Release, April 30, 2019.

Source: Novartis