Herzuma® (trastuzumab), a biosimilar for the treatment of breast cancer, now available in Europe
The Mundipharma global network of independent associated companies today announced that Herzuma, biosimilar trastuzumab, is now available in Europe, with the product now launched in both the UK and Germany and further launches across European countries anticipated in the coming months. The Mundipharma network has exclusive distribution rights to Herzuma in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands.
Richard Trollope, Head of Oncology and Biosimilars at Mundipharma International Limited, said: “Building on our partnership with Celltrion Healthcare, we are pleased to announce that biosimilar trastuzumab is now available in Europe with national launches commencing in both the UK and Germany. The availability of biosimilar trastuzumab will provide an alternative treatment option to the thousands of eligible patients across Europe with early breast cancer, metastatic breast cancer or metastatic gastric cancer.”
Herzuma, a biosimilar of i.v. Herceptin®, was granted marketing authorisation on 9th February 2018 for the treatment of patients with early breast cancer, metastatic breast cancer or metastatic gastric cancer whose tumours have either HER2 overexpression or HER2 gene amplification, following positive opinion and recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2017. Biosimilar trastuzumab has the potential to make significant cost savings for healthcare organisations, releasing healthcare resource for other innovative medicines.3
Alberto Martinez, President and CEO, Mundipharma International Limited, said: “Mundipharma has a proven track record of launching biosimilars successfully in Europe, which is illustrated by Celltrion Healthcare entrusting us once again with the launch of biosimilar trastuzumab across key European markets. As biosimilar trastuzumab continues to launch in additional countries, we look forward to assisting healthcare economies across Europe wanting to deliver better value to patients.”
Herzuma is the third biosimilar to be marketed and distributed by the Mundipharma network in Europe, having launched Remsima ® (infliximab), the first biosimilar monoclonal antibody, in 2015, and Truxima® (rituximab), the first biosimilar monoclonal antibody for the treatment of cancer, in 2017.
Notes to editors:
About the Mundipharma network
The Mundipharma global network of privately-owned independent associated companies, including Napp Pharmaceuticals Ltd in the UK, was founded in 1956 by doctors and now operates in over 120 countries worldwide. We are focused on developing business partnerships to identify and accelerate meaningful technology across an increasingly diverse portfolio of therapy areas including respiratory, oncology, pain, and biosimilars. Consistent with our entrepreneurial heritage, we like to think we see what others don’t by challenging conventional wisdom and asking different and challenging questions. By working in partnership with all our stakeholders, the Mundipharma network develops medicines that create value for patients, payers and wider healthcare systems.
For more information please visit: www.mundipharma.com.
Trastuzumab is a monoclonal antibody designed to target the HER2 receptor. When it binds to the receptor, trastuzumab reduces HER2 signalling that otherwise increases tumour stimulation, and also enables the immune system to target the cancerous tumour.4
It is administered on its own as monotherapy, as well as in combination with or following standard chemotherapy. Trastuzumab has changed the prognosis of patients with HER2 positive breast cancer, both in advanced and early stage disease.5
Biosimilar is a term used to describe officially approved subsequent versions of biopharmaceutical medicines that are made available by a different company following patent and exclusivity expiry on the original product. Biosimilars are classed as biologic medical products, which mean they contain an active drug substance that is comprised of, or derived from, a living organism. Biosimilars are strictly regulated and need to demonstrate comparability to the previously approved reference product via a thorough development programme including quality assurance, pre-clinical and clinical programmes.
®Herzuma is a registered trade mark of Celltrion, Inc. and is used under licence.
®Herceptin is a registered trade mark of Genentech, Inc.
1 Herceptin (trasutuzmab) Summary of Product Characteristics. Available online at: https://www.medicines.org.uk/emc/medicine/3567. Accessed April 2018
2 Herzuma (trastutuzmab) Summary of Product Characteristics. Available at: https://ec.europa.eu/health/documents/community-register/2018/20180209139854/anx_139854_en.pdf - Accessed April 2018
3 Delivering on the Potential of Biosimilar Medicines. March 2016. Available online at: https://www.coursehero.com/file/20466083/IMS-Institute-Biosimilar-Brief-March-2016/. Accessed April 2018
4 Gajria D, et al. HER2-amplified breast cancer: mechanisms of trastuzumab resistance and novel targeted therapies. Expert Rev Anticancer ther. 2011 Fe: 11 (2): 263-275
5 Bartsch, R et al. Trastuzumab in the management of early and advanced stage breast cancer. Biologics 2007; 1(1): 19–31
Communications Lead for Mundipharma
Telephone: +44 (0) 1223 397 3361
Om Business Wire
(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
Manchester United Shoots for Success with a “Digital Experience Platform” Powered by HCL16.8.2018 19:02 | Pressemelding
Manchester United (NYSE:MANU) has today announced a major milestone on its digital transformation journey with HCL Technologies, with the successful launch of the Manchester United Official app powered by HCL’s digital experience platform. The launch is part of the ongoing digital transformation of the club to provide a real-time, engaging, personalized, and unified experience to Manchester United’s 659 million global followers, which supports the club’s strategy to become a Digital Sports Enterprise. At the heart of this transformation is the digital platform developed by HCL, providing the club with a single view of fans across web and app touchpoints, offering fans a one-stop shop for everything Manchester United. Manchester United’s Group Managing Director Richard Arnold comments: “This app will allow our 659 million Manchester United followers to easily connect to the club they love, wherever they are in the world. Fans will now have the opportunity to follow all Manchester United
4K 4Charity Fun Run Announces Open Registration for IBC201816.8.2018 17:41 | Pressemelding
AWS Elemental, an Amazon Web Services (AWS) company, today announced that the fifth annual 4K 4Charity Fun Run at IBC Show will take place at 7:00 a.m. local time on Saturday, Sept. 15 at Amstelpark in Amsterdam. Registration is open at https://4k4charity.com/ibc. Among the non-profits supported by the 4K 4Charity Fun Run at IBC Show is Amsterdam-based StichtingNewTechKids, which provides computer science education for girls, minorities, and economically challenged youth in the Netherlands. The organization supports a computer science teacher training program for primary school teachers with proceeds from 4K 4Charity. Also supported is Iridescent, a global education non-profit that empowers underrepresented young people to become innovators and leaders through engineering and technology. Through their two programs, Curiosity Machine AI Family Challenge and Technovation, Iridescent introduces underserved communities to new technologies and empowers and equips them to apply those technol
2018 D.I.C.E. Cannes Announced Round 3 Speakers16.8.2018 14:01 | Pressemelding
The Academy of Interactive Arts & Sciences’ D.I.C.E. Cannes event will take place 9-11 September 2018 at the Hotel Barrière Le Majestic Cannes in France. Leading video game executives will participate in the premier networking opportunities, listen to key speakers address the conference theme - Trailblazers - to tackle some of the industry’s biggest ideas and trends. Newly announced speakers include: Craig Duncan, Studio Head at Rare – Duncan will share his studio’s experience and learnings with “A Rare Voyage of Adventure.” Duncan will provide insight into Rare’s bold new IP Sea of Thieves, a game that has inspired friendships and players creating stories together. David Hubert, Animation and Cinematic Director at Eidos Montreal – In Hubert’s talk he will discuss how cinematics are redefining AAA story-driven games and how they will continue to shape the medium to push the envelope throughout the production process. Adam Orth – In a session titled “Digging for Fire: Virtual Reality 20
GN Hearing and Google Announce Partnership to Bring Direct Mobile Streaming from Android Devices to Hearing Aids16.8.2018 13:00 | Pressemelding
GN Hearing and Google have today announced a new technology partnership that will make GN Hearing the first manufacturer to enable a full spectrum of direct audio streaming from Android devices to hearing aids. The expectations are that direct streaming will become available to hearing aid users of the recently launched hearing aids ReSound LiNX Quattro™ and Beltone Amaze™ in a future Android release. “According to the World Health Organization, around 466 million people worldwide have disabling hearing loss. This number is expected to increase to 900 million people by the year 2050. Google is working with GN Hearing to create a new open specification for hearing aid streaming support on future versions of Android devices,” states Seang Chau, Vice President of Engineering at Google. Users will be able to connect and monitor their hearing aids, so they can get the full advantages of their Android devices without using an intermediate device for streaming to their hearing aids. This will
Zurich Expands Global Use of Guidewire InsurancePlatform with Selection of Guidewire Cyence Risk Analytics16.8.2018 12:55 | Pressemelding
Guidewire Software, Inc. (NYSE: GWRE), the provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced that Zurich Insurance Group (Zurich) has selected Guidewire Cyence™ Risk Analytics (Cyence) to leverage the cyber risk knowledge and insights the solution provides to help the company prospect, underwrite, and price risks. Zurich will roll out Cyence globally with an emphasis on enhanced analytics and intelligence for risk selection. Unprecedented technological advances of the 21st century have shifted the nature of risk across the P&C insurance industry. Ever-evolving cyber risks present unique challenges including limited availability of traditional actuarial data needed to model these risks. Cyence combines economic modeling, cybersecurity, machine learning and Internet scale data collection to help risk takers assess the financial impact of cyber risk. “After conducting a thorough search, we found that the capabilities of Guidewire Cyence Risk
Scientist.com Named One of America’s Ten Fastest-Growing Private Companies by Inc. Magazine16.8.2018 12:06 | Pressemelding
Scientist.com, the world’s leading marketplace for outsourced scientific services, today announced that it ranked no. 9 on Inc. magazine’s 2018 list of the 5,000 fastest-growing, privately owned companies in America. Scientist.com ranked no. 2 nationally in the Health category and no. 2 in the state of California. The San Diego-based company builds private marketplaces that connect life science research organizations with a global network of over 2,600 contract research organizations (CROs) and providers of scientific services. “Our mission is to empower and connect scientists worldwide and make it possible to cure all human diseases by 2050,” stated Kevin Lustig, Scientist.com’s CEO and Founder. “On Scientist.com, a single, highly trained scientist can run an entire drug discovery program from concept to clinic from his or her laptop without ever physically entering a laboratory.” The pharmaceutical industry spends about $150B a year on medical research and produces about 25 new medic