Data presented at ECCO congress in nearly 600 patients with inflammatory bowel disease (IBD) supports switching from Remicade® to biosimilar infliximab

EMBARGO: 12.20 GMT+1, FRIDAY 18 MARCH 2016

 

Data presented at ECCO congress in nearly 600 patients with inflammatory bowel disease (IBD) supports switching from Remicade® to biosimilar infliximab

 

Ten independent studies validate the growing bank of real-life clinical evidence to support switching patients from the reference infliximab (Remicade®) to biosimilar infliximab1-10

Further evidence shows increased IBD physician familiarity with and acceptance of the efficacy and tolerability of biosimilars11

Real world practice also shows significant cost savings for healthcare systems made by switching patients to biosimilar infliximab1

 

Cambridge, UK, 18 March 2016 – Data presented today at the 11th Congress of European Crohn’s and Colitis Organisation (ECCO) adds to the growing body of real-world evidence that supports switching patients from reference infliximab to biosimilar infliximab. In total, data for 589 patients who were switched from reference infliximab to biosimilar infliximab in ten independent studies from across eight countries was presented at the congress.1-10 This comprised switch data from 325 patients with Crohn’s disease (CD), 128 patients with ulcerative colitis (UC) and 136 patients where the type of IBD was not specified.1-10

 

One study which included 74 IBD (56 CD and 18 UC) patients found comparable efficacy and safety after switching patients with IBD from the reference infliximab to biosimilar infliximab.2 Lead researcher, Professor Martin Kolář, Charles University, Prague, noted that between week 0 and week 24, there was no significant difference in C-reactive protein levels (4.3 ± 8.0 mg/l vs 3.6 ± 4.5; p = 0.78) or faecal calprotectin (135 ± 153 µg/g vs 226 ± 297; p = 0.44) observed. Likewise, no increase in immunogenicity was found (IFX trough levels: 3.4 ± 3.8 μg/ml vs 3.8 ± 3.3, p = 0.23; anti-drug antibodies positivity: 9.5% vs 10%, p = 0.79) and disease activity was stable until the end of follow up (remission at week 0 vs week 24: 72% vs 78%).2 In addition, the frequency and type of adverse events were similar to that observed during treatment with the reference infliximab.2

 

The largest single cohort of patient switch data was from a study by Southampton General Hospital in the UK, which included 134 IBD patients. The service outcome evaluation reported that there was no significant change in drug persistence between patients treated with the biosimilar and those treated with the reference product (p=0.49) and there was a similar incidence of expected side effects before and after switch.1 Furthermore, the IBD team concluded that switching to a lower cost biologic could offer considerable cost savings to healthcare systems and therefore investment in clinical services.1

 

Co-author of the study, Dr Fraser Cummings, Southampton General Hospital, UK, comments: “We worked with our commissioning team to develop a switch programme that enabled us to invest some of the savings made by using biosimilars to improve patient care in the department. These ‘gain share’ agreements allowed us to distribute the savings gained between the different stakeholders in the hospital and thus to directly fund a new IBD nurse, as well as clerical, pharmacist and dietetic support. Through this, we have made considerable improvements to the care we are able to offer our patients.”

 

Further data from a survey conducted by ECCO were also presented, which demonstrate the rapid evolution of IBD specialists’ thinking in favour of biosimilars since 2013 when research was last undertaken by the organisation. The survey of 118 IBD healthcare professionals found that most experts (92.4%) regarded potential cost savings as the main advantage of biosimilars.11 The survey also found that:11

Only a quarter (25%) of those asked would not extrapolate data across IBD classifications

75% felt that medical societies should promote information on biosimilars

Just under half (44%) of respondents considered the reference product and biosimilar to be interchangeable

Only 19.5% of physicians felt little or no confidence in the use of biosimilars

Only 35% of physicians agreed that biosimilars should carry distinct International Non-proprietary Names

Lead researcher Professor Silvio Danese, Humanitas Clinical and Research Center, Italy, comments: “This research demonstrates that IBD specialists are generally informed and well educated about biosimilars and it’s evident that physician confidence in biosimilars has grown since 2013. There are fewer concerns and increased confidence about the use of biosimilars in clinical practice.”

 

Mundipharma International Limited and its independent associated companies have distribution rights from Celltrion Healthcare Hungary Kft for Remsima® in Germany, Italy, UK, Netherlands, Belgium and Luxembourg. 

 

- Ends-

 

About the studies

1. DOP030 Elective switching from Remicade® to biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study (Smits, L et al)

In the study, 83 patients were switched to biosimilar CT-P13: 57 patients with CD, 24 patients with UC, and 2 patients with unclassified IBD

 

2. DOP032 Switching of patients with inflammatory bowel disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima®) is effective and safe (Kolar, M et al)

In the study, 74 patients were switched to biosimilar IFX after mean time of 3 ± 2.2 years on original preparation: 56 CD, 18 UC

 

3. DOP029 Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab (Bettey, M et al)

In the study, 134 IBD patients were switched to biosimilar IFX.

 

4. P329 Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study (Hamanaka, S et al)

In the study, 3 patients were switched from Remicade® to infliximab biosimilar: 1 UC, 2 CD

 

5. P449 Efficacy and safety of switching between originator and biosimilar infliximab in patients with inflammatory bowel disease in practical clinic: results to 6 months (Diaz Hernández , L et al)

In the study, 72 patients were switched from reference infliximab to biosimilar infliximab: 62 CD, 10 UC

 

6. P452 Safety and efficacy of infliximab biosimilar (Remsima®) in Crohn’s disease patients in clinical practice: results after 6 months of treatment (Guerra Veloz, M. F et al)

In the study, 71 patients with CD were switched from Remicade® to Remsima®

 

7. P544 Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD (Fiorino, G et al)

In the study, 93 patients were switched from reference infliximab to biosimilar infliximab: 51 CD, 42 UC. All patients were included in the safety evaluation and 82 of the 93 patients were included in the efficacy evaluation 

 

8. P600 Safety and efficacy of infliximab biosimilar (Remsima®) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment (Guerra Veloz, M. F et al)

In the study, 31 UC patients were switched from Remicade® to Remsima®

 

9. P617 Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn’s disease (Sieczkowska, J et al)

In the study, 16 paediatric CD patients were switched from reference infliximab to biosimilar infliximab

 

10. P655 Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel diseases: a 1-year, single-centre retrospective study (Hlavaty, T et al)

In the study, 12 patients were switched from reference infliximab to infliximab biosimilar CT-P13: 10 CD, 2 UC

 

11. P312 Has IBD specialists’ awareness of biosimilar monoclonal antibodies changed? Results from a survey amongst ECCO members (Danese, S et al)

In the study, 118 responders completed a 13-question anonymous survey

 

About Mundipharma

The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. The Mundipharma network has a presence in 51 countries with more than 7,800 employees across the world. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of pain management, oncology, respiratory and inflammatory conditions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers important treatments to meet the most pressing needs of patients, healthcare professionals and health systems worldwide.

For further information please visit: www.mundipharma.com

 

About Remsima®

Remsima® is a medicinal product containing a monoclonal antibody called infliximab. Following an extensive comparability exercise between Remsima® and the reference product it was demonstrated via quality, nonclinical and clinical data that all major physicochemical characteristics and biological activities of Remsima® were comparable to those of the reference product. The therapeutic indications as well as the dosing regimen for Remsima® are the same as those of the reference product; the pharmaceutical form (powder for concentrate for solution for infusion) and strength (100 mg infliximab per vial) are also the same.12 Remsima® is therefore indicated in the same settings as reference infliximab: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult and paediatric Crohn’s disease and adult and paediatric ulcerative colitis.12

 

About biosimilars

Biosimilar is a term used to describe officially approved subsequent versions of biopharmaceutical products that are made available by a different company following patent and exclusivity expiry on the original product. Biosimilars are classed as biologic medical products, which means they contain an active drug substance that is comprised of, or derived from, a living organism. Biosimilars are strictly regulated and need to demonstrate comparability to the previously approved product via a thorough development programme including quality, nonclinical and clinical data. As part of the comparability exercise for Remsima® it was shown that all major physicochemical characteristics and biological activities were comparable to those of Remicade®, which is the initial product in this instance.

 

For further information please contact:

Charlotte James

Mundipharma International Ltd

[email protected]

Tel: +44 (0) 1223 397162

 

Clare Cook

Golin

[email protected]

Tel: +44 20 7067 0613

 

References

Bettey, M et al. (2016) ‘DOP029 Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Kolar, M et al. (2016) ‘DOP032 Switching of patients with inflammatory bowel disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima®) is effective and safe’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Smits, L et al. (2016) ‘DOP030 Elective switching from Remicade® to biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Hamanaka, S et al. (2016) ‘P329 Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Diaz Hernández, L et al. (2016) ‘P449 Efficacy and safety of switching between originator and biosimilar infliximab in patients with inflammatory bowel disease in practical clinic: results to 6 months’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Guerra Veloz, M.F et al. (2016) ‘P452 Safety and efficacy of infliximab biosimilar (Remsima®) in Crohn’s disease patients in clinical practice: results after 6 months of treatment’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Fiorino, G et al. (2016) ‘P544 Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Guerra Veloz, M.F et al. (2016) ‘P600 Safety and efficacy of infliximab biosimilar (Remsima®) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Sieczkowska, J et al. ‘P617 Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn’s disease’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Hlavaty, T et al. (2016) ‘P655 Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel diseases: a 1-year, single-centre retrospective study’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands

Danese, S et al. (2016) ‘P312 Has IBD specialists’ awareness of biosimilar monoclonal antibodies changed? Results from a survey amongst ECCO members’ Abstract presented at the 11th Congress of ECCO, Amsterdam, Netherlands

Remsima SPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf

MINT/REMS-16011

March2016