Date: 2015-03-18
Type of
information: Presentation of results at a congress
phase:
Announcement: presentation of results at Digestive Diseases Week (DDW) 2015
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: Norway
Trial
details:
- The NOR-SWITCH Study will assess the safety and efficacy of switching from the RMP to biosimilar infliximab. (NCT02148640)
Latest
news:
- • On May 18, 2015, Celltrion Healthcare announced that clinical experience of biosimilar infliximab in 78 inflammatory bowel disease (IBD) patients presented at Digestive Diseases Week (DDW) 2015 in Washington D.C. showed that the treatment is comparable to the reference medicinal product (RMP) in terms of efficacy and safety. Speaking at a satellite symposium hosted by Celltrion Healthcare, Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, provided an update on his own clinical experience of treating patients with IBD in Norway with biosimilar infliximab, which represents the latest treatment development in IBD. The clinical data from 46 Crohn’s disease (CD) and 32 ulcerative colitis (UC) patients presented at the meeting showed a statistically significant reduction in disease activity at week fourteen. Among them, 22 patients (8 UC and 14 CD) were previously treated with other biologics. Of the patients with CD, 76% (32/42) were in clinical remission at week 14 after three infusions of biosimilar infliximab, with significant reductions also seen in calprotectin and CRP. For UC patients, 56 % (18/32) were in clinical remission at week 14 (partial Mayo score ? 2) following the three infusions, with significant reductions in Simple Activity Index, calprotectin and CRP.
- Discussions at the symposium focused on extrapolation of data and switchability and interchangeability of originator biologics and biosimilars. The speakers shared their experience with biosilmilars, explaining how extrapolation is inherent to the concept of biosimilarity and how interchangeability is widely accepted.
- The NOR-SWITCH Study, which will assess the safety and efficacy of switching from the RMP to biosimilar infliximab, was also discussed. The study is being will be undertaken in 18 hospitals across in Norway and aims to recruit 500 people. Data from this study are expected in 2016.
Is
general: Yes
