Samsung Bioepis verkrijgt met ONTRUZANT® als eerste positief oordeel van CHMP voor een biosimilair van Trastuzumab
INCHEON, Korea–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. heeft vandaag aangekondigd dat het Comité voor geneesmiddelen voor menselijk gebruik van het Europees Geneesmiddelenbureau (EMA) positief heeft geoordeeld over ONTRUZANT®, een biosimilair van Herceptin® (trastuzumab) voor de behandeling van vroege borstkanker, uitgezaaide borstkanker en uitgezaaide maagkanker.
Het positieve oordeel van CHMP wordt nu overgedragen aan de Europese Commissie, die een beslissing neemt over de verlening van vergunning voor het in handel brengen van ONTRUZANT®.
Samsung Bioepis First to Receive Positive CHMP Opinion on a Trastuzumab Biosimilar with ONTRUZANT® |
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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. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170915005388/en/  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. i Herceptin® is a registered trademark of Genentech Inc. View source version on businesswire.com: http://www.businesswire.com/news/home/20170915005388/en/ Contacts MEDIA CONTACT: |
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