samsung_bioepis

Samsung Bioepis’ Ontruzant becomes first Herceptin biosimilar approved in Europe

pharmafile | November 20, 2017 | News story | Sales and Marketing EMA, Herceptin, Roche, Samsung Bioepis 

Samsung Bioepis has announced that Ontruzant, the company’s biosimilar version of Roche’s Herceptin, has been awarded marketing authorisation in Europe by the EMA for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

The authorisation covers all 28 EU member states in addition to Norway, Liechenstein and Iceland and marks the fourth biosimilar from the company to be approved in the region. Samsung Bioepis has already secured approval for biosimilar versions of Humira, Remicade and Enbrel.

The South Korean company is hoping to carve out a slice of Herceptin’s market share after the drug generated $6.8 billion globally for Roche in 2016. It will have competition on its hands, as other companies such as Mylan, Biocon, Cellitron, Amgen and Allergan are all stepping into the space with their own biosimilar versions of the drug..

“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 Christopher Hansung Ko, President & CEO 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.”

Matt Fellows

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