Biosimilars could facilitate early access to life changing biological treatments for patients says Celltrion Healthcare

Payers, physicians and health economists highlighted the importance of biosimilars in improving early access for patients to biological treatment

BALTIMORE--(BUSINESS WIRE)-- 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.

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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.

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Source: Celltrion Healthcare