Date: 2017-02-17
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO)
Company: Celltrion Healthcare (South Korea) Pfizer (USA - NY)
Product: CT-P13 - Inflectra®/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. It was approved by the FDA under the trade name Inflectra in april 2016. 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: Crohn's disease
Therapeutic
area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country:
Trial
details:
- CT-P13 3.4 CD RCT is a randomised, double-blind, parallel- group, phase 3 study to investigate efficacy and safety between CT-P13 and reference infliximab with CD patients. Out of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed up to week 6 for the primary analysis, and 180 patients completed up to week 30. The study was funded equally by Celltrion and Pfizer.
Latest
news:
-
• On February 17, 2017, Celltrion Healthcare and Pfizer announced that the presentation of primary outcome from their pivotal randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO), Celltrion Healthcare. The data indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease (CD) is comparable to those treated with reference infliximab. The Phase III RCT in 220 patients with CD examined whether CT-P13 is comparable to reference infliximab as determined by the Crohn’s Disease Activity Index (CDAI), a measurement used to quantify the symptoms of CD patients. According to the 6 week and 30 week data, similar clinical remission, CDAI-70 and CDAI-100 response rates were observed in both CT-P13 and reference infliximab treatment groups.
- Celltrion Healthcare also presented data from two observational studies. The first study evaluated the efficacy and safety of CT-P13 in 74 paediatric patients with CD (naïve patients: 26, switch patients: 25) or ulcerative colitis (UC) (naïve patients: 16, switch patients: 7). The data show that CT-P13 is effective in both treatment-naïve and switch paediatric patients over 30 weeks and is well-tolerated.
- The second study examined 204 CD patients (fistulising CD: 24, CD patients: 180) in South Korea from July 2012-2016. CT-P13 was found to be clinically consistent to reference infliximab and well tolerated up to six months in patients with moderate-to-severe CD and those with fistulising CD.
- CT-P13 has delivered significant health savings across Europe: Real-world cost savings associated with the use of CT-P13 across all indications were studied in five European countries from the beginning of 2015 to the first half of 2016. According to the data presented at ECCO, total cost savings observed for Germany, Italy, Spain and the UK amounted to €32.4 million and the findings suggest that this could allow an additional 5,428 patients a year access to this important biologic therapy. There were no cost savings in France, as the price of biosimilar and reference infliximab were the same, however despite this, use of CT-P13 has gradually increased in this country.
Is
general: Yes
