Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar – Pharma News

Sandoz, a key player in generic and biosimilar medicines, on Monday announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending marketing authorization for their biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc.

According to a press statement, the positive opinion for Sandoz trastuzumab, a monoclonal antibody, covers treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, the same indications as approved by EMA for the reference biologic.

The generic drugmaker stated that Sandoz and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix will remain responsible for the development and manufacturing of trastuzumab, while Sandoz will hold the rights to commercialize the medicine upon approval in respective markets.

“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,” Pierre Bourdage, Chief Commercial Officer, Sandoz, said in a statement.

In Europe, the impact of both breast and gastric cancers is significant. Every year, over 355,000 women are diagnosed with breast cancer and, with 92,000 deaths per year, it is the number one cause of cancer death among women.

Gastric cancer is the sixth most common of all cancer types and, with 107,000 deaths annually, it is the fourth most common cause of cancer-related death in Europe. In up to 20 percent of breast cancers and up to 30 percent of gastric cancers diagnosed, an HER2 protein overexpression (or HER2 gene amplification) is detected resulting in an uncontrollable growth and division of cells. HER2 cancers are particularly aggressive cancer types that respond well to targeted treatment, as per experts.

Sandoz has a stronghold across a range of areas including immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development.

Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation, it stated.


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