Biosimilars could facilitate early access to life changing biological treatments for patients says Celltrion Healthcare
At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Celltrion Healthcare today advocated for healthcare systems to introduce biologics earlier in a patient’s treatment regimen in order to improve clinical outcomes.
Several studies show that the early introduction of biologics can bring greater clinical benefit to patients.1,2,3,4,5,6 However, only a limited number of patients have access to biological treatment due to the high-cost of biologics and current reimbursement policies determined by pharmacoeconomic evaluations. Since the introduction of biosimilars, the overall cost of biological treatments has reduced in Europe, allowing an increased number of patients to access this important treatment option earlier in their course of treatment.7
Professor Jørgen Jahnsen said, “For the treatment of inflammatory bowel disease, biological treatments are proven to be the most efficacious medical therapy and their early introduction can provide better outcomes. To offer those living with Crohn’s disease or ulcerative colitis the best treatment, we must increase patient access to biological treatments at the most optimal time. The introduction of biosimilars can facilitate this.”
Speaking at ISPOR, Professor Gulácsi, Head of Department of Health Economics, Corvinus University of Budapest HTA Consulting, Hungary, concluded that, “According to the budget impact study of CT-P13, if budget savings were spent on reimbursement of additional biosimilar infliximab treatment, approximately 10-15% more patients could be treated in high and middle-income countries.”
Mr HoUng Kim, Head of Strategy and Operations at Celltrion Healthcare, addressed the issue of limited early access to biological treatment at the congress in a statement:
“Patients should have the option of receiving the best possible treatment as early as possible. As a company we are strongly committed to delivering innovative and affordable treatments for people living with chronic conditions across the world by providing high quality, cost effective biosimilars. Now is the time for payers, physicians and health economists to re-evaluate the cost effectiveness of biological treatment in light of the introduction of biosimilars and to address inconsistencies in patient access.”
Mr HoUng Kim went on to explain that a lack of understanding of biosimilars in some healthcare systems, doctors’ conservative prescribing behaviours and the high development and manufacturing costs associated with biologics as current obstacles when seeking to treat patients early with biological therapies..
The Celltrion Healthcare presentation as ISPOR also included perspectives from leading physicians:
- Professor Jørgen Jahnsen, Akershus University Hospital, Norway shared his perspective on the early introduction of biologics in inflammatory bowel disease, showing that the early introduction of anti-TNF alpha agents brought the most clinical benefit to patients
- Professor László Gulácsi, Corvinus University, Hungary provided an overview on how reducing healthcare costs can result in improved access to treatments
- Dr Edmund Pezalla, Former Vice President, Aetna, U.S. provided an analysis of the uptake of biosimilars in United States healthcare environment.
Notes to editors:
Dr Edmund Pezalla, Former Vice President, Aetna, U.S., said: “President Trump’s recent blueprint marks as an important step toward lowering the prices of prescription drugs in the United States. This decision is promising to expand access to biosimilars and raising awareness about the potential of biosimilars to lower drug costs. As this appears to be a major endorsement of price transparency, and also allow Medicare Part D plan sponsors to promote lower cost generics and biosimilars, there’s no doubt that the tide is finally turning for patient access to very expensive treatments for complex conditions at lower costs.”
About inflammatory bowel disease
Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.8 They affect an estimated 2.5-3 million people in Europe;9 CD affects about three people per 1,000 and UC about 5 people per 1,000.8
IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.9
About CT-P13 (biosimilar infliximab)
CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 87 countries (as of May 2018) including the US, Canada, Japan and throughout Europe.
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: http://www.celltrionhealthcare.com/
1 G D'Haens, et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomised trial. Lancet 2008; 371: 660–67.
2 Colombel JF, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N EnglJ Med. 2010 Apr 15;362(15):1383-95.
3 Colombel JF, et al. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2017 Oct 30. pii: S0140-6736(17)32641-7.
4 St Clair EW, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. ArthritisRheum.2004 Nov;50(11):3432-43.
5 Baranauskaite A, et al. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study. Ann Rheum Dis. 2012;71:541-548
6 Emery P, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanerceptin active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet. 2008 Aug 2;372(9636):375-82.
7 IMS Health. The Impact of Biosimilar Competition. June 2016. Available at: file:///C:/Users/gfeatherston/Downloads/IMS%20Impact%20of%20Biosimilar%20Competition%202016.pdf
8 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54.
9 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis. 2013; 7,322-337.
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
Traxens Gains Confidence of Tens of Top 500 Beneficial Cargo Owners20.2.2019 07:00:00 | Pressemelding
Traxens, expert in providing high-value data and services for the supply chain industry, today announces that it signed several contracts with some of the top 500 Beneficial Cargo Owners (BCO), including major companies such as BASF. Under the terms of the agreements, Traxens provides door-to-door data monitoring solutions for smart containers supplied by partnering shipping lines. BCOs are typically industrial companies importing and exporting large volumes of goods in containers. Traxens’ customers operate in various industries such as aeronautics, pharmaceuticals, chemicals, automotive and foods. These firms require cutting-edge data monitoring systems for easy and reliable management of stocks, actionable analytics and cost reductions. Traxens’ Supply Chain Diagnostic solution enables near real-time monitoring with custom alerts through its web application Traxens-Hub or direct back-end integration, as well as bespoke analysis of transportation performance, thus enabling process op
Sonitor® Technologies AS Spins-Out Forkbeard as Subsidiary and Establishes New Corporate Structure20.2.2019 07:00:00 | Pressemelding
The Board of Directors of Sonitor Technologies AS announced today that it is establishing Sonitor IPS Holding AS (Indoor Positioning Systems) and creating two subsidiaries; Sonitor Technologies AS and Forkbeard Technologies AS. Forkbeard Technologies will focus on the development of platform technologies for cloud-based, indoor positioning of mobile devices. Sonitor Technologies will continue to focus on the commercialization and expansion of the market leading Sonitor Sense™ platform and will partner in the commercialization of the Forkbeard™ technology platform in healthcare and other markets. “After careful consideration, the Board of Directors has determined that separating Sonitor into two independent entities will accelerate the growth and development of each and lead to greater shareholder value,” said Carl Christian Gilhuus-Moe, PhD, Executive Chairman, Sonitor Technologies AS. “The current Sonitor Board of Directors will continue as the board of directors for Sonitor IPS Holdi
Guidewire Software Announces Hexaware as New Consulting Alliance Partner19.2.2019 21:15:00 | Pressemelding
Hexaware Technologies, a fast growing automation-led, next generation provider of IT, BPO and consulting services, and Guidewire Software, Inc. (NYSE: GWRE), provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced that Hexaware has joined Guidewire PartnerConnect™ as a Consulting alliance member at the Select level. With over 20 years’ experience working with P&C insurers, Hexaware has developed value-add solution and technology offerings that enable insurers to rapidly adopt Guidewire InsuranceSuite™ and Guidewire Digital products, increasing speed to implementation, mitigating execution risk, and lowering costs. Hexaware has supported Guidewire customer success in APAC and EMEA and offers localized solutions for insurers in these regions. “Digital technology is disrupting the P&C insurance industry at an unprecedented rate, and insurers are leveraging market-leading platforms, such as Guidewire InsurancePlatform™, to deliver differentiated pr
IFF Acquires The Additive Advantage; Expands Scent, Taste, and Actives Delivery Capabilities19.2.2019 21:15:00 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), has expanded and strengthened its innovation capabilities for scent, taste and active ingredients through the acquisition of The Additive Advantage (TAA), a company that develops novel technologies with diverse capabilities that span applications and industries. TAA has the expertise to develop the next-generation delivery systems technology platform that will enable the printing of flavors, fragrances, cosmetic and health & nutrition actives onto a variety of consumer products. IFF Chairman & CEO Andreas Fibig said, “The acquisition of TAA helps to expand our large portfolio of offerings to customers in a truly unique way – through print technology. With the expertise that this talented group of people brings under our roof, we envision taking delivery systems to a completely new level and ultimately enriching how consumers experience our customers’ products.” “We are genuinely exci
Rockwell Automation and Schlumberger Enter Joint Venture Agreement to Create Sensia, the Oil and Gas Industry’s First Fully Integrated Automation Solutions Provider19.2.2019 21:05:00 | Pressemelding
Rockwell Automation (NYSE: ROK), the world’s largest company dedicated to industrial automation and information, and Schlumberger (NYSE: SLB), the world's leading provider of technology for reservoir characterization, drilling, production, and processing to the oil and gas industry, announced today that they have entered into an agreement to create a new joint venture, Sensia, the first fully integrated digital oilfield automation solutions provider. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190219005851/en/ The transaction is expected to close, and the joint venture is expected to begin serving customers, in the summer of 2019, subject to regulatory approvals and other customary conditions. The Sensia joint venture will be the first fully integrated provider of measurement solutions, domain expertise, and automation to the oil and gas industry. It will offer scalable, cloud and edge-enabled process automation, includin
IDEMIA Will Present Its 2018 Annual Financial Results to Investors on February 20, 201919.2.2019 16:07:00 | Pressemelding
IDEMIA, the world leader in Augmented Identity, today announced that it will present its 2018 annual financial results to investors on Wednesday February 20, 2019. Yann Delabrière (CEO), Laurent Lemaire (CFO), and Frédéric Beylier (COO) will be presenting the financial results and taking questions the same day at 4:00 pm CET (3:00 pm London Time / 10:00 am New York Time). For more information, please refer to our website: http://investors.oberthur.com About IDEMIA IDEMIA, the global leader in Augmented Identity, provides a trusted environment enabling citizens and consumers alike to perform their daily critical activities (such as pay, connect, travel and vote), in the physical as well as digital space. Securing our identity has become mission critical in the world we live in today. By standing for Augmented Identity, an identity that ensures privacy and trust and guarantees secure, authenticated and verifiable transactions, we reinvent the way we think, produce, use and protect one of