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/
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170915005388/en/
Contact information
MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Reply Announces the Jury for the First AI Music Contest: Finalists Will Perform Live on Stage at Kappa FuturFestival in Turin23.5.2025 11:05:00 EEST | Press release
Reply, an international group specialized in the creation of new business models enabled by Artificial Intelligence and driven by a strong culture of innovation, is expanding its creative experimentation initiatives this year with the launch of the AI Music Contest. Organised in collaboration with Kappa FuturFestival, one of Europe’s leading electronic music festivals, the competition is open to creatives and innovators who use AI technologies to explore new forms of integration between sound and visuals. It aims to enhance the expressive potential of artificial intelligence in live performances. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250523250887/en/ The jury members include prominent figures such as Seth Troxler and DJ Tennis, who are renowned DJs and producers known for their pioneering use of AI in live performances. Also on the panel is Albertino, a DJ, radio host and the artistic director of Radio m2o. Alongsid
Kioxia Holdings Corporation Wins IPO of the Year Award in the Equity Category at the DealWatch Awards 202423.5.2025 10:00:00 EEST | Press release
Kioxia Holdings Corporation (TOKYO:285A), a world leader in memory solutions, today announced that it had won the IPO of the Year award in the Equity category at the DealWatch Awards 2024, organized by DealWatch, the most authoritative source of real-time intelligence for deal activity within Japan's capital markets. The award was presented at a ceremony held on May 20. The DealWatch Awards recognize outstanding issuers of bonds or equities in the Japanese capital market, as well as Japanese issuers who have conducted offerings overseas, and the securities firms that manage these transactions. The awards for 2024 comprised six categories: Overall, Bonds, Local Government Bonds, Cross-Border Bonds, Sustainable Finance, and Equity. Selection is based on criteria such as the appropriateness of pricing in the issuance market, price formation after transition to the trading market, contribution to the development of capital markets, and innovative efforts, with the awards designed to promot
Generix Named in the 2025 Gartner® Magic Quadrant™ for Warehouse Management Systems (WMS) for the Seventh Consecutive Year23.5.2025 10:00:00 EEST | Press release
Generix, a global business software company offering an expansive portfolio of SaaS solutions for supply chain, finance, commerce, and B2B integration, today announces it has been recognized by Gartner in the 2025 Gartner® Magic Quadrant™ for Warehouse Management Systems (WMS). This is the seventh consecutive year that Generix has been recognized for its portfolio of WMS Solutions. Designed to scale as supply chain operations grow from simple to complex flows, Generix WMS and Solochain WMS are currently in more than 2,000 warehouses globally. “We are honored to be recognized in the Gartner® Magic Quadrant™ WMS for the seventh consecutive year. Generix continues its commitment to providing WMS for every warehousing need at a global scale. With our two recognized WMS solutions, Generix WMS and Solochain WMS, we continue to innovate to better serve customer needs with the introduction of industry game-changing AI use-cases such as resource planning and computer vision,” said Si-Mohamed Sa
NuORDER by Lightspeed and Mandatory Renew Partnership to Power Hybrid Commerce at the Third Edition of the Copenhagen Event23.5.2025 10:00:00 EEST | Press release
Mandatory and NuORDER by Lightspeed, the industry’s leading B2B commerce platform, are joining forces for the third consecutive time to power the digital extension of Mandatory’s in-person trade event, taking place August 5–7 in Copenhagen. This renewed partnership reflects the continued momentum behind hybrid commerce—where physical and digital trade intersect to create smarter, more flexible buying experiences. As the Nordic fashion ecosystem expands with energy and innovation, Mandatory has become a magnet for trendsetting brands and forward-looking retailers. On NuORDER’s wholesale platform, buyer activity from Nordic-region retailers surged by 39.4% year over year in Q1 2025 (January to March). "Retailers in the Nordic region have been quick to adopt digital tools to enhance the efficiency of their buying processes. The increase in buyer activity on the NuORDER platform early this year clearly indicates a growing market demand and a renewed engagement within the industry," said Ch
Curatis discloses Corticorelin as active substance of C-PTBE-0123.5.2025 08:00:00 EEST | Press release
An epidemiological market study commissioned by Curatis Holding AG (SIX:CURN, “Curatis”) shows that the target patient group is substantially larger than previous estimates. In the US alone, over 150,000 patients suffer from peritumoral brain edema in association with malignant tumors. In previous clinical studies, human corticorelin (C-PTBE-01), demonstrated significant benefits in the treatment of PTBE. “The prospect of developing a potential blockbuster drug with that can contribute significantly to the quality of life of many patients, combined with the potential of maintaining the efficacy of immunotherapies for these patients, is very motivating and exciting,” said Dr. Roland Rutschmann, Curatis CEO. Key statements Corticorelin (hCRH), a 41 amino acid endogenous polypeptide, has demonstrated the ability to positively impact the blood-brain barrier after a disruption due to the underlying malignant tumor. Curatis intends to develop corticorelin to treat PTBE in primary and metasta
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom