Clinical Trials

Date: 2018-08-09

Type of information: Completion of the trial

phase: 3

Announcement:

Company: Celltrion Healthcare (South Korea)

Product: Remsima® SC (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:

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country:

Trial details:

Latest news:

• On August 29, 2018, Celltrion announced that the company has completed Phase 3 clinical trial for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab, with the preparation for filing a Marketing Authorization Application to the European Medicines Agency (EMA) now in the final stage, such as the analysis of clinical data.
In a bid to obtain its competitiveness in the TNF-? inhibitor (autoimmune disease therapeutic agent) market through ‘twin-track’ strategy together with the existing intravenous (IV) formulation of Remsima®, Celltrion has developed Remsima SC, the SC version of infliximab. Since May 2016, Celltrion has conducted Phase 1 and Phase 3 clinical trials on the safety, pharmacokinetic and efficacy assessment of Remsima SC.
The subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle unlike the intravenous formulation that require patients to visit hospitals for the administration there of.