Celltrion Healthcare: Switching to Remsima®▼ (infliximab) from originator has no negative effect on safety or efficacy in 10 real-world studies

Physician view of monoclonal antibody biosimilars increasingly positive as real-world evidence and experience grows

AMSTERDAM--(BUSINESS WIRE)--Real-world studies with nearly 600 inflammatory bowel disease (IBD) patients in eight countries show comparable efficacy and safety following a switch to biosimilar infliximab from originator infliximab.^1-10 These studies, presented at the 11^th Congress of the European Crohn’s and Colitis Organisation (ECCO), further support the appropriate switching of patients to Remsima®, a cost-effective alternative to originator infliximab, and build on the wealth of real-world evidence of the safety and efficacy of Remsima® accumulated since its launch a year ago.

As physician experience with biosimilar infliximab has grown, so has confidence in monoclonal antibody biosimilars. The results of a survey of ECCO members presented at the ECCO congress show that only 19.5% of respondents feel little or no confidence in the use of biosimilar monoclonal antibodies compared to 61% of respondents to a previous version of the survey undertaken in 2013.¹¹ The survey also shows that positive switching studies with biosimilar infliximab have helped to reassure physicians about switching from the originator, with 44.4% of respondents considering the originator and biosimilar to be interchangeable, compared with only 6% in the 2013 survey.

Professor Silvio Danese, head of the IBD Center at the Istituto Clinico Humanitas and lead author of the survey, said: “Biosimilar infliximab was the first monoclonal antibody to become available so there was some understandable trepidation around the time of launch. However, as people have been able to use the treatment, and with the large number of real-world and post-marketing studies now available, increasing numbers of clinicians are confident to use monoclonal antibody biosimilars. It is important that post-marketing and longer term studies with biosimilar infliximab are reported in order to further reassure clinicians and patients about biosimilars.”

The positive results of the biosimilar infliximab switching studies are further supported by two long-term follow up studies presented today at a Celltrion Healthcare satellite symposium. The extension studies of PLANETAS¹² and PLANTETRA¹³ – the phase 3 trials that supported the approval of Remsima® – were performed to investigate the efficacy and safety of maintenance treatment with Remsima® over two years as well as the efficacy and safety of switching to Remsima® from originator infliximab for one year. Clinical efficacy, immunogenicity and safety were highly comparable between the maintenance and switch groups in both extension studies. Importantly, there were no signs of altered efficacy, safety or immunogenicity profiles following the switch to Remsima® from the originator. Furthermore, the proportion of immunogenicity-related safety events was similar between maintenance and switched rheumatoid arthritis and ankylosing spondylitis patients.

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “We know that physicians value real-world as well as clinical evidence and have worked hard to ensure these data are available. We now have a remarkable volume of data showing the comparable safety and efficacy of Remsima® in both treatment-naïve patients and those who have been switched to Remsima® from originator infliximab. We’re delighted to see a corresponding growth in physician confidence with monoclonal antibody biosimilars, and in willingness to switch to a biosimilar from the originator. This suggests that more patients will get the chance to benefit from biological therapies, particularly for conditions that require chronic treatment such as IBD.”

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Notes to editors:

About the switching studies

Abstract	Title	Authors	# of switched patients
DOP029	Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab	F. Cummings, et al.	134 (indications unclassified)
DOP030	Elective switching from Remicade® to biosimilar CT-P13 in Inflammatory Bowel Disease patients: A prospective observational cohort study	L. Smits, et al.	83 (CD: 57 UC: 24 Unclassified IBD: 2)
DOP032	Switching of patients with Inflammatory Bowel Disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima®) is effective and safe	M. Kolar, et al.	74 (CD: 56, UC: 18)
P329	Infliximab biosimilar in the treatment of Inflammatory Bowel Disease: A Japanese single cohort observational study	S. Hamanaka, et al.	3 (CD: 2, UC: 1)
P449	Efficacy and safety of switching between originator and biosimilar infliximab in patients with Inflammatory Bowel Disease in practical clinic: Results to 6 months	L. Díaz Hernández, et al.	72 (CD: 62, UC: 10)
P452	Safety and efficacy of infliximab biosimilar (Remsima©) in Crohn’s Disease patients in clinical practice: Results after 6 months’ treatment	M.F. Guerra Veloz, et al.	71 (CD)
P544	Prospective observational study on IBD patients treated with infliximab biosimilars: Preliminary results of the PROSIT-BIO cohort of the IG-IBD	N. Manetti, et al.	97 (IBD)
P600	Safety and efficacy of infliximab biosimilar (Remsima©) in Ulcerative Colitis disease patients in clinical practice: Results after 6 months treatment	M.F. Guerra Veloz, et al.	31 (UC)
P617	Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn disease	J. Sieczkowska, et al.	16 (paediatric CD)
P655	Biosimilar infliximab CT-P13 treatment in patients with Inflammatory Bowel Diseases: A one year, single-center retrospective study	T. Hlavaty, et al.	12 (CD: 10, UC: 2)

Further data for biosimilar infliximab presented at the 11^th Congress of ECCO

• OP003 P.A. Golovics, et al. Predicting short and medium-term efficacy of the biosimilar infliximab: trough levels/ADAs or clinical/biochemical markers play a more important role?
• DOP010 A. Bálint, et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort.
• DOP028 K. Gecse, et al. Efficacy and safety of biosimilar infliximab after one year: results from a prospective nationwide cohort.
• DOP031 R. Bor, et al. Efficacy of infliximab biosimilar CT-P13 therapy on mucosal healing in ulcerative colitis – data from two Central European countries.
• DOP033 B. Lovasz, et al. Immunogenicity profile and predictors of TLs and ADA development of biosimilar infliximab during the first 6 months of the therapy: results from a prospective nationwide cohort.
• P311 D. Duricova, et al. No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: Short-term results.
• P327 L. Carvalho Lourenço, et al. Biosimilar infliximab in real-life Crohn’s disease’s anti-TNF alpha naïve patients: a comparative observational cohort study (SIMRECRO study).
• P382 R. Muhammed, et al. Comparison of efficacy and safety of biosimilar infliximab to originator infliximab in children with inflammatory bowel disease.
• P484 P. Lakatos, et al. Access to biologics and biosimilars across 11 EU countries.
• P495 M. Bortlik, et al. Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naïve to antiTNF therapy: a tertiary centre experience.
• P513 E. Zagorowicz, et al. Comparison of infliximab the originator and biosimilars in treatment of Crohn’s Disease: a Polish cohort study.
• P519 M. Kaniewska, et al. Efficacy and safety of biosimilar of infliximab (Inflectra) in adult patients with Crohn’s disease during one year of treatment followed by 6 months of observation – one centre retrospective study.
• P530 J. Sieczkowska, et al. Efficacy of biosimilar infliximab induction therapy in paediatric patients with Crohn’s Disease –1.5 years of experience.
• P577 N. Turk, et al. Croatian database from 5 centers – efficacy and safety of infliximab biosimilar in treatment of IBD patients.
• P645 M. Kaniewska, et al. Efficacy and safety of biosimilar of infliximab in rescue therapy in adult patients with severe ulcerative colitis.

About inflammatory bowel diseases

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. They affect an estimated 2.5-3 million people in Europe;¹⁴ CD affects about three people per 1,000 and UC about 5 people per 1,000.¹⁶

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.¹⁷

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 with the FDA Arthritis Advisory Committee recommending approval of all indications of Celltrion’s biosimilar infliximab in February 2016.

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 Cummings F, et al. Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab. 11^th Congress of ECCO. DOP029.

² Smits L, et al. Elective switching from Remicade® to biosimilar CT-P13 in Inflammatory Bowel Disease patients: A prospective observational cohort study. 11^th Congress of ECCO. DOP030.

³ Kolar M, et al. Switching of patients with Inflammatory Bowel Disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima™) is effective and safe. 11^th Congress of ECCO. DOP032.

⁴ Diaz Hernández L, et al. Efficacy and safety of switching between originator and biosimilar infliximab in patients with Inflammatory Bowel Disease in practical clinic: Results to 6 months. 11^th Congress of ECCO. P449.

⁵ Sieczkowska J, et al. Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn disease. 11^th Congress of ECCO. P617.

⁶ Hamanka S, et al. Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study. 11^th Congress of ECCO. P329.

⁷ Guerra Veloz MF, et al. Safety and efficacy of infliximab biosimilar (Remsima) in Crohn’s disease patients in clinical practice: results after 6 months of treatment. 11^th Congress of ECCO. P452.

⁸ Fiorino G, et al. Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD. 11^th Congress of ECCO. P544.

⁹ Guerra Veloz MF, et al. Safety and efficacy of infliximab biosimilar (Remsima) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment. 11^th Congress of ECCO. P600.

¹⁰ Hlavaty T, et al. Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel diseases: a 1-year, single-centre retrospective study. 11^th Congress of ECCO. P655.

¹¹ Danese S, et al. Has IBD specialists’ awareness of biosimilar monoclonal antibodies changed? Results from a survey among ECCO members. 11^th Congress of ECCO. P312.

¹² Park W, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605-12. Available at: ard.bmj.com/content/early/2013/05/16/annrheumdis-2012-203091.full [accessed March 2016].

¹³ Yoo D H, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613-20. Available at: ard.bmj.com/content/early/2013/05/20/annrheumdis-2012-203090.full.pdf [accessed March 2016].

¹⁴ Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.