Business Wire

Celltrion Receives EU Approval for Trastuzumab Biosimilar

Del

Celltrion, Inc. (KRX:068270) announced today that the European Commission (EC) approved Herzuma® (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 14, 2017.

“The development of biosimilar is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal against a variety of diseases and to increase patients’ accessibility to innovative drugs at a more affordable price,” said Woosung Kee, Chief Executive Officer of Celltrion. “We have already seen many benefits of biosimilars in Europe from our experience with Remsima® and Truxima®1. Our experience has shown that biosimilars not only reduce individual patient’s out-of-pocket medical expenses but also contribute to lowering financial burden on insurance payers and national health agencies.”

The European Commission’s approval of Herzuma® marks an important milestone for Celltrion, providing more treatment options for patients. Herzuma® is the third biosimilar from Celltrion’s portfolio approved by the EC.

This decision by the European Commission means that Herzuma® is now approved for marketing in the 28 member states of the European Union (EU), in addition to Norway, Liechtenstein and Iceland.

About Herzuma®

Herzuma® is an anticancer monoclonal antibody (mAb) biosimilar drug used to treat breast cancer and gastric cancer. Similarity of Herzuma® to the reference product, Herceptin®2, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. In 2017, Celltrion launched Herzuma® in Korea.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for Inflectra® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. Celltrion also received EC’s approval for Truxima® (CT-P10, a mAb biosimilar to MabThera®3 (rituximab)) in February 2017. For more information, visit www.celltrion.com.

1 Celltrion’s mAb products Remsima® (infliximab biosimilar) and Truxima® (rituximab biosimilar) were approved by the EC in September 2013 and February 2017, respectively.

2 Herceptin® is a registered trademark of Genentech, Inc.

3 MabThera® is a registered trademark of F. Hoffmann-La Roche AG.

Contact information

Celltrion, Inc.
Gunn Lee, +82 32 850 5168
Gunhyuk.lee@celltrion.com
or
Heewon Park, +82 32 850 5356
Heewon.park@celltrion.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

The European Project AMable Launches Its First Open Call17.7.2018 08:00Pressemelding

The European Project AMable has launched its First Open Call to find innovative ideas for additively manufactured products. The selected teams will be supported by AMable to develop an idea towards a final product by offering the services across all steps from design to finish. As a Factories of the Future (FoF) project participating in I4MS (ICT for Manufacturing SMEs) and with the support of the European Union's Horizon 2020 research and innovation programme, the aim of AMable project is to accelerate the uptake of additive manufacturing (AM) technologies; from design to manufacture for functional parts throughout the European Union. AMable is creating a digital framework to provide impartial access to the best European AM knowledge to support this adoption. This knowledge will be offered as advanced and tailored services to assist SMEs in the uptake of AM and include technological, business and training services. For this Open Call, the European Project is looking for original ideas

Norsk Titanium Marks Milestone in U.S. Production17.7.2018 07:00Pressemelding

The University of Notre Dame Turbomachinery Laboratory (NDTL), Norsk Titanium US, Inc. (Norsk), Pratt & Whitney and TURBOCAM International are collaborating to develop and test additively manufactured turbomachinery components. This collaboration will focus on exploring the applicability of Norsk’s Rapid Plasma Deposition™ (RPD™) material to turbomachinery applications. As part of this effort, NDTL will test an additively manufactured integrally bladed rotor (IBR) produced and inspected to meet the applicable quality specifications used in Pratt & Whitney’s current turbomachinery components. The team has completed the initial phase of testing, with TURBOCAM International conducting machining trials of Norsk’s RPD™ material, and Pratt & Whitney successfully inspecting the material to the same specification as forged turbomachinery components. The material’s manufacturing qualities were evaluated for applicability to TURBOCAM’s precision milling processes. “We were very pleased with the

More Than Half of Sub-Saharan Africa to Be Connected to Mobile by 2025, Finds New GSMA Study17.7.2018 07:00Pressemelding

More than half the population of Sub-Saharan Africa will be subscribed to a mobile service by 2025, according to the latest edition of the GSMA’s Mobile Economy report series, published at the GSMA ‘Mobile 360 – Africa’ event being held in Kigali this week. The new report forecasts that there will be 634 million unique mobile subscribers1 across Sub-Saharan Africa by 2025, equivalent to 52 per cent of the population, up from 444 million (44 per cent) at the end of last year. The report also calculates that the mobile ecosystem will add more than $150 billion in value to Sub-Saharan Africa’s economy by 2022, equivalent to almost 8 per cent of regional GDP. “For many citizens across the region, particularly those living in rural areas, a mobile phone is not just a communications device but also the primary channel for getting online and a vital tool for improving their lives,” commented John Giusti, Chief Regulatory Officer at the GSMA. “More needs to be done to extend connectivity to th

GSMA Finds That Consumers in Developing Countries Are Hard Hit by High Spectrum Prices17.7.2018 06:00Pressemelding

Better spectrum pricing policies are needed in developing countries to improve the economic and social welfare of the billions of people that remain unconnected to mobile broadband services, according to a new report, ‘Spectrum Pricing in Developing Countries’, released by the GSMA today at the Mobile 360 – Africa conference in Kigali. The study reveals that spectrum prices in developing countries are, on average, more than three times higher than in developed countries, when income is taken into account. This high spectrum pricing is a major roadblock to increasing mobile penetration. Authored by GSMA Intelligence, the study also found that governments are playing an active role in increasing spectrum prices to maximise state revenues from spectrum licensing. High spectrum prices are linked to countries with high levels of sovereign debt, and alarmingly average reserve prices in spectrum auctions are more than five times higher in developing countries than in developed, once income is

NEC and dotData Use AI to Accelerate Data Science for the SMBC Group17.7.2018 04:38Pressemelding

NEC Corporation (NEC) (TOKYO:6701) and dotData, Inc., a Silicon Valley venture in the automation of data science, today announced the provision and full operation of “dotData” platform for the Sumitomo Mitsui Financial Group, Inc. (SMBC Group) in order to strengthen the Group’s analytical capabilities. In recent years, the need for big data analytics has been growing rapidly. However, there is also an increasing shortage of data scientists to handle this need. In order to address this issue, dotData automates data science processes through artificial intelligence (AI). dotData platform is now commercially available globally. NEC has obtained an exclusive license from dotData to provide this software across Japan. Sumitomo Mitsui Banking Corporation, NEC and the dotData team have actively worked to incorporate AI into banking operations in order to create new service offerings since 2016. Following this success, the SMBC Group is now expanding the provision of dotData platform throughou

Cushman & Wakefield To Acquire Its Irish Affiliate From Sherry FitzGerald Group16.7.2018 13:49Pressemelding

Global real estate services firm Cushman & Wakefield today announces it has entered into a definitive agreement to acquire the commercial property arm of Sherry FitzGerald Group in the Republic of Ireland. The deal is expected to complete in early September 2018. Cushman & Wakefield already has a 20% stake in the Irish commercial property business which operated as its exclusive affiliate in the Republic – rebranding two years ago as Cushman & Wakefield Ireland. The firm, which has more than 100 commercial property professionals and offices in Dublin, Limerick and Galway, will now be fully integrated into Cushman & Wakefield, one of the world’s largest real estate services firms with 48,000 employees in approximately 400 offices and 70 countries. Managing Director Aidan Gavin becomes Cushman & Wakefield’s Head of Ireland and will also sit on the firm’s UK & Ireland Executive Committee. Cushman & Wakefield will maintain its close affiliate relationship with the wider Sherry FitzGerald G