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Samsung Bioepis First to Receive Positive CHMP Opinion on a Trastuzumab Biosimilar with ONTRUZANT®

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Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ONTRUZANT ® , a biosimilar candidate referencing Herceptin ® (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

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

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

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide on the grant of a marketing authorization for ONTRUZANT ® . If a marketing authorization is granted by the EC, ONTRUZANT ® will be commercialized in the European Union by MSD, which is known as Merck in the United States and Canada.

“We are proud to see ONTRUZANT become the first trastuzumab biosimilar recommended for approval in Europe, where breast cancer remains the most common form of cancer affecting women. If approved, 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.”

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.

Contact information

MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com

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