Samsung Bioepis Receives Regulatory Approval for Europe’s First Trastuzumab Biosimilar, ONTRUZANT®

INCHEON, Korea

Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) marketing authorization of ONTRUZANT^®, a biosimilar referencing Herceptin^® (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. ONTRUZANT^® is the first trastuzumab biosimilar to receive regulatory approval in Europe.

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Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)

The EC approval of ONTRUZANT^® applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. ONTRUZANT^® will be commercialized by MSD, which is known as Merck in the United States and Canada.

“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.”

ONTRUZANT^® is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing authorization. Samsung Bioepis has also received marketing authorizations for Benepali^® (etanercept), Flixabi^® (infliximab) and Imraldi^® (adalimumab).

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

ⁱ Herceptin^® is a registered trademark of Genentech Inc.

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