Sandoz has signed an agreement with EirGenix for the commercialisation of a trastuzumab biosimilar.

Trastuzumab is a monoclonal antibody (mAb) designed to treat certain breast and gastric cancers. It selectively targets the human epidermal growth factor receptor 2 (HER2) protein, which is present on both normal and HER2+ tumour cells.

Under the terms of the agreement, EirGenix will develop and manufacture the biosimilar, while Sandoz holds the right to commercialise it worldwide, except China and Taiwan.

Sandoz Biopharmaceuticals global head Stefan Hendriks said: “Every year, approximately 300,000 people worldwide are diagnosed with HER2-positive breast cancer, which tends to spread more quickly than HER2-negative tumours, making swift treatment important.

“Approximately 300,000 people worldwide are diagnosed with HER2-positive breast cancer.”

“While targeted therapy is available, high out-of-pocket costs lead to limited treatment in the US and reimbursement issues have resulted in varying uptake in Europe.

“Introducing biosimilars can help create earlier and expanded access to this important medicine, which is why I am so excited about the potential for this collaboration.”

Under the agreement, Sandoz will make an undisclosed upfront payment to EirGenix, along with milestone payments. The Taiwanese company is also eligible for profit shares on sales in the territories.

The agreement brings the number of biosimilar drugs in Sandoz’s oncology portfolio to five. The company markets a total of eight biosimilars and has more than ten compounds in development.

Of the total marketed biosimilars, four are for cancer, three in supportive cancer care and one is to treat blood cancers.