Celltrion, Inc.: No Difference In Efficacy Or Immunogenicity Following Switch To Remsima®? (Infliximab) From Originator

New data show comparable efficacy and safety to originator infliximab in both biologic-naïve and switch patients

BARCELONA, Spain--(BUSINESS WIRE)--New clinical data indicate no differences in efficacy, adverse events and immunogenicity when patients with inflammatory bowel disease (IBD) are switched to the biosimilar infliximab Remsima^® from originator infliximab (the reference medicinal product or RMP).¹ The study results, presented at United European Gastroenterology Week (UEG Week) 2015 in a satellite symposium sponsored by Celltrion Healthcare, add to growing real-world evidence that patients already being treated with the RMP can be appropriately switched to Remsima^®, a more cost-effective treatment option.

In the Czech Republic, a total of 74 IBD patients (Crohn’s disease [CD]: 56, ulcerative colitis [UC]: 18) in remission on long term treatment with the RMP were switched to Remisma^®. After a median follow up of 24 weeks, results from the study showed good efficacy for Remsima^® with the same maintenance of remission, minimal adverse events – including immunogenicity – and no difference in allergic reactions compared to the RMP. The same trough levels of infliximab were seen in patients receiving Remsima^® compared to historical data for the RMP.¹

Speaking at UEG Week, Professor Milan Lukas, IBD department head, Clinical and Research Center for IBD, ISCARE Clinic, Prague, said: “Following the approval of biosimilars in Europe, there has been a lot of discussion about whether it is possible to alternate or switch from the originator product to the biosimilar in clinical practice. Although the follow up period is relatively short and the number of patients is small, we have found biosimilar infliximab to be comparable to the originator in both switch and anti-TNF naïve patients and are encouraged that others around the world are having similar experiences.”

Professor Lukas also presented data from a further cohort of 93 anti-TNF naïve IBD patients (CD: 69, UC: 24) from the Czech Republic at the symposium. The study showed that the clinical efficacy of Remsima^®, measured by a decrease in inflammatory activity shown in endoscopic assessment of mucosal healing (endoscopy subscore of 0 or 1) for UC or biological remission markers including C-reactive protein, fecal calprotectin and clinical symptomatology for CD, was comparable to a retrospective cohort of the RMP.¹

Details of a real-world study of IBD patients from South Korea were also presented at the symposium. In the post-marketing study of 173 patients (CD: 95, UC: 51), both treatment-naïve patients and patients who had previously received the RMP were treated with Remsima^® and followed for 30 weeks.² The study results published in the September edition of Expert Review of Gastroenterology and Hepatology, show that Remsima^® is well tolerated and efficacious in IBD patients. Comparison of the study results with historical data for the RMP suggests that clinical outcomes such as safety and efficacy are comparable for Remsima^® and the RMP, reinforcing the clinical similarity of the two treatments.²

Additional real-world data supporting the safety and efficacy of switching to biosimilar infliximab from the RMP were presented at UEG Week in three poster presentations:

• Gecse K, et al. Biosimilar infliximab: efficacy and safety based on interim results from a prospective nationwide cohort in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. Abstract P0970, poster sessions, Tuesday, October 27, 09:00 – 17:00; Hall 7
• Sieczkowska J, et al. First experience of switching between originator and biosimilar infliximab in paediatric inflammatory bowel disease patients. Abstract 0P096, poster sessions, Monday, October 26, 16:45 – 16:57; Room A2
• Lovasz B et al. Immunogenicity of the biosimilar infliximab: interim results from a prospective nationwide cohort. Abstract P0351, poster sessions Monday, October 26, 09:00 – 17:00; Hall 7

As the world’s first EMA-approved monoclonal antibody biosimilar, Remsima^® is singular in terms of the cumulative real-world data available in both treatment-naïve patients and those who have been switched to the biosimilar from the RMP. Clinical experience of biosimilar infliximab in patients with IBD was presented in six posters and a satellite symposium^{3,4,5,6,7,8,9} at the 2015 European Crohn’s and Colitis Organisation annual meeting, as well as in published case studies.^10,11 These earlier data also show that treatment with biosimilar infliximab is effective and well tolerated in patients with UC and CD.

Dr Stanley Hong, President and CEO of Celltrion Healthcare, said: “The new real-world experience with Remsima^® in IBD adds to the expanding body of clinical evidence. Biosimilar infliximab can support greater and earlier access to biological therapies while reducing the financial burden on healthcare systems around the world. Switching to biosimilars offers comparable clinical benefits at a lower price, allowing medical communities to realize higher cost-savings. We are committed to ensuring as many IBD patients as possible benefit from this important therapy.”

Further data for Remsima^® were also presented at UEG Week:

• Jarzebicka D, et al. First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. Abstract P0370 Monday, October 26, 09:00 – 17:00; Hall 7
• Kim Y H. Early effectiveness in inflammatory bowel disease patients who were treated with CT-P13 (biosimilar infliximab). Abstract P1594 Wednesday, October 28, 09:00 – 17:00; Hall 7
• Molnar T, et al. Efficacy of the new infliximab biomarker CT-P13 (biosimilar infliximab) induction therapy on mucosal healing in ulcerative colitis patients. Abstract P1605 Wednesday, October 28,
  09:00 – 17:00; Hall 7
• Dreesen E, et al. Anti-Remicade antibodies cross-react with the biosimilars Remsima and Inflectra in patients with inflammatory bowel disease. Abstract OP097 Monday, October 26, 16:57 – 17:09; A2

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Notes to editors:

About inflammatory bowel diseases (IBD)

Inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis, are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.¹² They affect and estimated 2.5-3 million people in Europe;¹³ CD affects about three people per 1,000 and UC about 5 people per 1,000.¹²

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.¹³

About biosimilar infliximab

The biosimilar infliximab developed and manufactured by Celltrion, Inc. is the world’s first biosimilar monoclonal antibody to be approved by the European Medicines Agency (EMA) for treatment of eight autoimmune diseases. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. It is currently being reviewed by the U.S. FDA.

About Celltrion Healthcare

Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries, including both developed and emerging markets. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA’s cGMP and the EMA’s GMP standards. For more information please visit: www.celltrionhealthcare.com/

Celltrion Healthcare has established a vast distribution network of partners and experts who have in-depth knowledge and experience in their local markets. In European markets, Celltrion Healthcare is in partnership with the following companies:

• Astro Pharma: Austria
• Biogaran: France and Monaco
• DEMO S.A.: Cyprus
• Egis: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Bulgaria, Czech Republic, Latvia, Lithuania, Poland, Romania, Slovakia, Russia, Ukraine, Uzbekistan and Hungary.
• Hospira: Europe
• Iceland: Portfarma
• Kern Pharma: Spain
• Medical Logistics: Malta
• Mundipharma: Belgium, Germany, Italy, Luxembourg, the Netherlands and the UK (Napp)
• Oktal Pharma d.o.o: Slovenia, Croatia, Bosnia-Herzegovina and Serbia
• Orion: Denmark, Estonia, Finland, Norway, and Sweden
• PharmaKern: Portugal
• Pinewood: Ireland
• Switzerland: iQone Healthcare

References

¹ Lukas M. Clinical experience with biosimilar infliximab (Remsima) in IBD patients. Celltrion Healthcare satellite symposium. United European Gastroenterology Week 23rd annual meeting 2015.

² Park S H, et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expet Rev Gastroenterol Hepatol. 2015;9(1):35-44. Available at: www.tandfonline.com/doi/full/10.1586/17474124.2015.1091309 [accessed October 2015].

³ Real world experience in IBD, Jørgen Jahnsen, Professor of Medicine and Gastroenterology at the University of Oslo. ECCO Satellite Symposium 2015.

⁴ Suk JY, et al. Efficacy and safety of infliximab’s biosimilar (Remsima) for IBD. ECCO 2015. P540.

⁵ Gecse K, et al. Biosimilar infliximab in inflammatory bowel diseases: first interim Results from a prospective nationwide observational cohort. ECCO 2015. P314.

⁶ Jarzebicka D, et al. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. ECCO 2015. P295.

⁷ Sieczkowska J, et al. Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report. ECCO 2015. P430.

⁸ Jarzebicka D, et al. First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. ECCO 2015. P456.

⁹ Molnar T, et al. Efficacy of the new infliximab biomarker CT-P13 induction therapy on mucosal healing in ulcerative colitis patients. ECCO 2015. P603.

¹⁰ Jung YS et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study. J Gastroenterol Hepatol 2015. doi: 10.1111/jgh.12997.

¹¹ Kang YS et al. Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series. Dig Dis Sci 2015. DOI: 10.1007/s10620-014-3392-z.

¹² 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. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [accessed October 2015].

¹³ Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn’s and Colitis (2013)7,322-337.