Date: 2016-03-18
Type of
information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO)
Company: Celltrion Healthcare (South Korea)
Product: Remsima® (biosimilar infliximab)
Action
mechanism:
- monoclonal antibody/biosimilar. The biosimilar infliximab developed and manufactured by Celltrion 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. 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), Kern Pharma (Spain), Medical Logistics (Malta), Mundipharma (Belgium, Germany, Italy, Luxembourg, the Netherlands and the UK), Oktal Pharma (Slovenia, Croatia, Bosnia-Herzegovina and Serbia), Orion (Denmark, Estonia, Finland, Norway, and Sweden), PharmaKern (Portugal) and Pinewood (Ireland).
Disease: inflammatory bowel disease, Crohn’s disease, ulcerative colitis
Therapeutic
area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: Czech Republic, South Korea
Trial
details:
Latest
news:
- • On March 18, 2016, Celltrion annouced the presentation of real-world studies at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO). The 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. 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. 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. 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.
- • On October 27, 2015, Celltrion announced that 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). 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 reference medicinal product 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 reference medicinal product. The same trough levels of infliximab were seen in patients receiving Remsima® compared to historical data for the reference medicinal product.
- 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 reference medicinal product.
- 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.
Is
general: Yes
