CELLTRION-HEALTHCARE

Celltrion Healthcare outlined their vision of ‘shaping future healthcare by improving access to biosimilars’ at the 5^th Annual Biosimilars USA Conference in New Jersey, US.

Biosimilars offer healthcare providers and patients greater treatment choice and value, better access to treatments and improved patient outcomes. According to data provided by IMS Health, biosimilars could lead to cumulative savings of up to 107 billion USD by 2020 in the United States (US) and the top five European Union (EU) countries.¹ The EU has made significant progress in unlocking the potential of biosimilars through continuous education of providers, payers and patients. This has been critical to EU biosimilar acceptance but has not been seen in the US, which has lagged behind.

During a presentation on the opportunities and challenges presented by the use of biosimilars in the US, Celltrion Healthcare highlighted several challenges affecting the uptake of biosimilars within the US market. Both physicians and patients in the US lack confidence in biosimilars due to a low level of education and awareness. According to a survey, 67% of patients said they were “unaware” of biosimilars and 70% selected “no” as a response to the statement “is a biosimilar is safe?”^2,3 Compounding this lack of understanding are anti-biosimilar campaigns running in the US which are increasing the negative public perception of biosimilars. In addition, legal battles like patent litigation have restricted uptake of biosimilars and have hindered progress in the US.

The lower cost of biosimilars means that more patients can receive effective treatments without increasing healthcare budgets. Furthermore, treatment at a lower cost generates savings that can be put towards funding innovative treatments or combination treatments, ultimately benefitting more patients and on a longer-term basis.

“A key factor in overcoming barriers to US market entry is sharing the positive experiences of both healthcare professionals and patients. In particular, it is important to highlight best practice and work together to ensure as many patients as possible in the US have access to treatment through the use of high quality, more cost-effective biosimilars,” said Mr HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare. “As innovators within the biosimilar field, we are looking forward to launching subcutaneous infliximab next year. We expect that this will generate further cost savings in addition to improved convenience as dual formulations would provide personalised therapeutic approaches to optimise patient outcomes.”

At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2018 which took place last week in Barcelona, Spain, Celltrion Healthcare presented new financial forecast data, which showed European health services could save hundreds of millions of euros through the use of biosimilars. For example, predicted budgetary savings in the 28 countries of the European Union with trastuzumab biosimilar, range from €872 million to €2,635 million, which would allow up to an additional 134,000 patients to gain access to trastuzumab over a five-year period.⁴

Speaking at ISPOR, Professor Gulácsi, Head of Department of Health Economics, Corvinus University of Budapest, Hungary, discussed the long term benefits and cost-effectiveness of TNFi treatment, including biosimilar infliximab, in methotrexate-naïve patients with rheumatoid arthritis (RA), “Our systematic review and meta-analysis has demonstrated the long-term benefits of TNFi treatment versus other treatment strategies in methotrexate-naïve patients with RA. Results from our probabilistic Markov model demonstrated that biosimilar infliximab in early RA is cost effective in Denmark, Finland, Sweden, Norway, France, Germany, Italy, Spain, the United Kingdom and Hungary. Infliximab biosimilar intravenous is the most cost effective option at this time, and I believe that this advantage will be further strengthened by the introduction of subcutaneous formulation."

“Budget impact modelling is an important tool when assessing the financial impact of biosimilars,” said Aidan Byrne, Consultant, Health Economics and Outcome Research / Real-World Insights, IQVIA, United Kingdom. “Due to the significant cost-saving we have seen to date, the role that biosimilars play in improving the sustainability of healthcare systems is clear.”

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Notes to editors:

About rheumatoid arthritis
In Europe, more than 2.9 million people have rheumatoid arthritis (RA), many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.⁵ Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

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 major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra^® . CT-P13 is approved in more than 88 countries (as of August 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/

References

¹ Delivering on the potential of biosimilar medicines—The role of functioning competitive markets IMS institute for healthcare informatics; 2016
² Cohen H, Beydoun D, Chien D, et al. Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians. Adv Ther. 2016;33(12):2160-2172.
³ Jacobs I, Singh E, Sewell KL, Al-sabbagh A, Shane LG. Patient attitudes and understanding about biosimilars: an international crosssectional survey. Patient Prefer Adherence. 2016;10:937-48
⁴ Suh D, Suh DC, Lee SM. PCN69: Budget Impact of Substituting Biosimilar Trastuzumab (CT-P6) In Treating Gastric Cancer and Breast Cancer in 28 European Countries. Poster presented at: ISPOR Europe 2018.
⁵ NRAS, European Fit for Work Report. Available at www.nras.org.uk/european-fit-for-work-report . [Accessed Aug, 2018].

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