Newly Presented Data From The Largest Real World Study To Date Demonstrate Effectiveness Of Biosimilar Infliximab In Patients With Inflammatory Bowel Diseases Who Have Been Switched From Reference Infliximab

In a study of 397 patients with ulcerative colitis and Crohn’s disease, 93 patients (23%) were switched to a biosimilar infliximab from the reference infliximab, representing the largest group of switch patients studied to date in inflammatory bowel diseases (IBD)¹

The results demonstrate comparable efficacy and safety in those patients who were switched, compared to those who were naïve to anti-tumour necrosis factor alpha (anti-TNFα) and to those who had previously been exposed to one or more biologics¹

Data from the PRospective Observational cohort Study on patients with Inflammatory bowel disease receiving Therapy with BIOsimilars (PROSIT-BIO) in patients with ulcerative colitis (UC) and Crohn’s disease (CD) has been presented at the Italian Group for the Study of IBD (IG-IBD), VII National Congress, Palermo, Italy.¹ The study of 397 patients (174 UC and 223 CD) – the largest of its kind to date – demonstrated that those who were switched from reference infliximab to biosimilar infliximab (93 patients) demonstrated comparable efficacy to those patients receiving a biosimilar who had previously been naïve to anti-TNFα (217 patients) and to those receiving a biosimilar who had previously been exposed to one or more biologics (87 patients) (response rate 95% vs. 92% vs. 91%, respectively).¹ Safety was also found to be comparable across the patient groups.¹

“These data, even though preliminary, demonstrate in real life that switching patients to biosimilar infliximab from reference infliximab results in comparable outcomes for patients, and that biosimilar infliximab is also effective in those patients who are anti-TNFα naïve or who have previously been exposed to one or more biologics,” commented Professor Silvio Danese, Head of the IBD Center, Department of Gastroenterology, Istituto Clinico Humanitas, Milan, Italy and one of the authors of the study. “The data also show that biosimilar infliximab had a comparable safety profile over the duration of the study. Biosimilars are cost effective options which can help to save money for health systems and these data suggest there is a comparable response and safety profile.”

In the study, 93 patients (42 UC and 51 CD) were switched after a mean of 14±13 previous infusions of infliximab (range 1-71), 231 patients received Remsima▼and 165 patients received Inflectra▼.^1 * Biosimilars may represent a cost-effective option for patients and health systems which have limited resources available.

Further switch data on Remsima is expected from the ‘Nor-Switch’ study funded by the Norwegian government, with data expected to be reported in 2016. Five hundred patients across all indications will be switched to Remsima from reference infliximab in this study, with occurrence of disease worsening as the primary endpoint.²

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

About The PROSIT-BIO study¹
The PRospective Observational cohort Study on patients with inflammatory bowel disease receiving Therapy with BIOsimilars (PROSIT-BIO) was conducted in 49 centres in Italy in 397 subjects with IBD. The study included 223 Crohn’s disease (CD) and 174 ulcerative colitis (UC) patients. The median age at diagnosis for CD patients was 30.6 ±14.4 years and for UC patients, 38.9±14.3 years. 217 patients were naïve to anti-TNFα (105 CD, 112 UC), 87 patients (67 CD and 20 UC) had a previous exposure to one or more biologic (26 infliximab, 59 adalimumab, 6 golimumab, 2 ustekinumab) and 93 patients (51 CD and 42 UC) were switched after a mean of 14±13 previous infusions of infliximab (range 1-71). There were 1116 infusions: 165 patients received Inflectra (total number of infusions = 405) and the remaining 231 received Remsima (total number of infusions = 711). Follow-up was 82.8 years/patient. The primary endpoint was safety at 12 months and the secondary endpoints were efficacy of biosimilars at 12 months, immunogenicity and predictive factors for efficacy and safety.

About Mundipharma
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and inflammatory conditions. They are also committed to independent thinking and ground breaking solutions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers cutting-edge treatments to meet the most pressing needs of healthcare professionals and patients. For more information, visit www.mundipharma.com.

About Remsima
Remsima is a medicinal product containing a monoclonal antibody (mAb) called infliximab. Following an extensive comparability exercise betweenRemsima 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.3 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.³

About Biosimilar
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.

^* Remsima and Inflectra are both brand names of the biosimilar infliximab developed and manufactured by Celltrion, Inc.

References:

¹ G Fiorino et al. Prospective observational study on safety and efficacy of infliximab biosimilar in patients with inflammatory bowel disease: preliminary results of the PROSIT-BIO cohort. Presented at the Italian Group for the Study of IBD (IG-IBD), VII National Congress, Palermo, Italy

² NOR-SWITCH Study. Tore K Kvienhttps://clinicaltrials.gov/ct2/show/NCT02148640?term=Remsima &rank

³ Remsima Assessment Report 27 June 2013,http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf