The agreement between the two companies will see Sandoz commercialize the medicine, upon approval, in all markets excluding China and Taiwan.
Taiwan-based EirGenix, a biotechnology manufacturing and development company, will continue to develop and manufacture the proposed Herceptin (trastuzumab) biosimilar.
Roche’s Herceptin is a treatment for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric tumors.
Currently, the proposed trastuzumab biosimilar in this deal is entering Phase III trials. In May 2017, EirGenix released details of the drug candidate demonstrating bioequivalence to Herceptin in a Phase I trial.
Through the agreement, EirGenix will receive an upfront payment, milestone payments, and a share of profits from sales. Further financial details of this agreement have not been disclosed.
This is the third biosimilar collaboration for Sandoz in the past 18 months, including its agreement with Biocon to develop, manufacture, and commercialize multiple immunology and oncology biosimilars.
Approval of the Herceptin biosimilar would expand Sandoz’ oncology portfolio, which currently includes four biosimilar in the area. As a whole, Sandoz has eight marketed biosimilars and over 10 in development.
For Roche, the number of biosimilar competitors to Herceptin continues to grow, with approvals for rival products in the European Union and the US.