European regulators have approved the first biosimilar of Roche’s blockbuster biologic Herceptin, issuing a green light for Samsung Bioepis’ Ontruzant.
The decision allows marketing of the drug in all 28 European Union member states and the European Economic Area member states of Norway, Iceland and Liechtenstein for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
It follows a positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in September, which agreed that Ontruzant (trastuzumab) is highly similar to reference product Herceptin (trastuzumab).
Herceptin currently pulls in nearly $7 billion a year in sales. Pricing information for Ontruzant is not yet available, but biosimilar versions are expected to be significantly cheaper than their reference products, and thus have the potential to generate substantial savings for healthcare providers.
"Breast cancer remains the most common form of cancer affecting women. We hope Ontruzant will play an important role expanding patient access to trastuzumab across the region," said the company’s president and chief executive Christopher Hansung Ko, president and chief executive of Samsung Bioepis.
"Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more cancer patients and healthcare systems across Europe will benefit from biosimilars."
Ontruzant is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing authorisation, following Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab).