INCHEON, Korea--(BUSINESS WIRE)--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.
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.
