Samsung Bioepis First to Receive Positive CHMP Opinion on a Trastuzumab Biosimilar with ONTRUZANT®
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/
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
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.
Samsung Bioepis Co., Ltd.
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Skriv dig op her og modtag pressemeddelelser på mail. Indtast din mail, klik på abonner og følg instruktionerne i den udsendte mail.
Flere pressemeddelelser fra Business Wire
VA-CTA24.5.2018 17:02 | pressemeddelelse
Hisense's Zhou Houjian and Huawei's Kevin Ho to Keynote CES Asia; Focus on Mobility, 5G and Connectivity
LIBERTEX24.5.2018 16:31 | pressemeddelelse
Maximum Cryptocurrencies Available for EU Traders in Libertex
CA-ANDERSEN-TAX24.5.2018 15:32 | pressemeddelelse
Andersen Global’s Middle East Expansion Continues with Solutions Bridge in Kuwait
IA-WORKIVA24.5.2018 15:02 | pressemeddelelse
Workiva Signs OEM Agreement with SAP to Offer SAP® Cloud Platform Integration with the Workiva Wdesk Platform
M-BRAIN24.5.2018 14:27 | pressemeddelelse
M-Brain Appoints New CEO
HYBRID-STOCK-EXCHANGE24.5.2018 14:15 | pressemeddelelse
IBIN Introduced into Billion Dollar Blockchain Market by Hybrid Stock Exchange
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter, og finde vores kontaktoplysninger.Besøg vores nyhedsrum