Business Wire

Samsung Bioepis Receives Regulatory Approval for Europe's First Trastuzumab Biosimilar, ONTRUZANT®

Del

Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) marketing authorization of ONTRUZANT ® , a biosimilar referencing Herceptin ® (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. ONTRUZANT ® is the first trastuzumab biosimilar to receive regulatory approval in Europe.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171119005066/en/

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

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

The EC approval of ONTRUZANT ® applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. ONTRUZANT ® will be commercialized by MSD, which is known as Merck in the United States and Canada.

“Breast cancer remains the most common form of cancer affecting women. 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.”

ONTRUZANT ® is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing authorization. Samsung Bioepis has also received marketing authorizations for Benepali ® (etanercept), Flixabi ® (infliximab) and Imraldi ® (adalimumab).

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Cushman & Wakefield Files Registration Statement for Proposed Initial Public Offering20.6.2018 17:20Pressemelding

Cushman & Wakefield today announced that it has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to the proposed initial public offering of its ordinary shares. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Morgan Stanley, J.P. Morgan, Goldman Sachs & Co. LLC and UBS Investment Bank will serve as joint book-running managers and representatives of the underwriters for the offering. Barclays Capital Inc., BofA Merrill Lynch, Citigroup Global Markets Inc., Credit Suisse Securities (USA) LLC and William Blair & Company, L.L.C. will also serve as joint book-running managers for the offering. The offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, J.P. Mor

Emirati Businessman and Philanthropist Abdul Aziz Al Ghurair Establishes an Education Fund for Arab Refugee Children & Youth From Countries Affected by Wars and Disasters20.6.2018 17:15Pressemelding

On World Refugee Day, Abdul Aziz Al Ghurair, Emirati businessman and philanthropist, announced the Abdul Aziz Al Ghurair Refugee Education Fund, a new 100M AED initiative to benefit 5,000 children and youth over 3 years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180620006060/en/ His Excellency Abdul Aziz Al Ghurair, Emirati businessman and philanthropist (Photo: AETOSWire) Abdul Aziz Al Ghurair said: “I established this fund because I believe that philanthropists have a role in helping to address one of the most acute challenges of our region: lack of education opportunities for young people who need it the most.” The Fund will award grants to support secondary, vocational and tertiary education programs for refugee youth in Jordan and Lebanon. It will also support children of families who due to wars and disasters in their home countries, temporarily reside in the UAE but are unable to afford school fees. The first rou

Bentley Systems Acquires Synchro Software to Extend Digital Workflows for Infrastructure Project Delivery Through 4D Construction Modeling20.6.2018 15:10Pressemelding

Bentley Systems, Incorporated, a leading global provider of comprehensive software solutions for advancing infrastructure, today announced the acquisition of Synchro Software, headquartered in London, leader (and the market creator) in 4D construction modeling software, for scheduling and project management. Synchro, “construction’s time machine,” has been globally adopted, in particular, for building and civil infrastructure projects. The acquisition broadens Bentley’s ProjectWise construction offerings—which already include ConstructSim, the leader for 4D construction modeling in project delivery of industrial plants. With construction project management in 4D, benefits of BIM can extend throughout infrastructure project delivery and asset lifecycles, as traditionally disconnected workflows become digital workflows. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180620005867/en/ Synchro 4D construction modeling of Crossrai

Austrian Tom Sipos Crowned elit® Vodka Art of the Martini Global Winner20.6.2018 14:33Pressemelding

After three days of shaking and stirring in Bilbao, Spain, elit® Vodka is delighted to announce that Tom Sipos of the Austrian Bar Academy is the winner of the esteemed elit® Art of the Martini challenge. Now in its third year, elit Vodka Art of the Martini is the biggest global city-based drinks competition, pitting the world’s best bartenders against one another in their home countries before inviting the 20 finalists to the Basque Country for a celebration of imagination and freedom, of purity and precision, and to rethink the hardest cocktail of them all – the martini – in the spirit of elit Vodka. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180620005843/en/ Austrian bartender Tom Sipos has been crowned elit Vodka Art of Martini global champion. This year's finals took place in Bilbao, ahead of The World's 50 Best Restaurants awards celebration. (Photo: Business Wire) Alessandro Palazzi, head bartender and Master of t

Quadient Holds the Top Leadership Position in the 2018 Aspire Leaderboard for Customer Communications Management20.6.2018 14:30Pressemelding

www.quadient.com : Quadient, formerly GMC Software, announced today the 2018 Aspire Leaderboard for Customer Communications has ranked Quadient as the top leader in the market for Customer Communications Management (CCM), Omni-Channel Orchestration and Overall CCM. Aspire Customer Communications Services independently evaluated 17 vendors’ current offerings and strategies to create the Aspire Leaderboard with the purpose of promoting CCM as a distinct segment within the wider Customer Experience (CX) market. A Neopost company with more than 350 full-time developers dedicated to CCM and CX, Quadient is committed to innovation. It is the only company to bring data quality capabilities and customer communications together in a comprehensive portfolio with flexible implementation options, including on-premise, hybrid and cloud solutions for a variety of users and business requirements. Working with Quadient and utilizing its Quadient Inspire solution, organizations have the power to levera

Entrust Datacard Announces Ambitious Collaboration with IBM Security to Help Secure the Mobile Workforce20.6.2018 14:23Pressemelding

Entrust Datacard, a leading provider of trusted identity and secure transaction technology solutions, today announced an expanded integration with IBM MaaS360 with Watson, an industry-leading AI-enabled unified endpoint management (UEM) solution. As threats, capabilities and technology continue to evolve, the solutions we turn to for digital trust must protect — but also enable — a drive towards improved business outcomes that reduce IT costs and complexity through streamlined access mechanisms. Governments and mobile-first enterprises — those that want to use mobile technologies to access sensitive data while eliminating the need for passwords and hardware tokens — should look for derived credentials from NIST 800-157 compliant vendors with the most secure technologies that do not impede employees’ work. The integrated solution from Entrust Datacard and MaaS360 delivers an end-to-end mobile solution designed to provide today’s companies with a new level of confidence in securing their