Celltrion Data Supports Subcutaneous Remisma For IBD
Also Backs Biosimilar For Crohn’s Disease And Ulcerative Colitis
Celltrion has published Phase I data supporting the use of its subcutaneous formulation of biosimilar infliximab to treat inflammatory bowel disease. The results follow a positive CHMP opinion for using subcutaneous Remsima to treat rheumatoid arthritis.
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In this podcast discussion, Generics Bulletin’s David Wallace talks to Informa Pharma Consulting’s Duncan Emerton about Celltrion’s CHMP nod for subcutaneous Remsima, the product’s imminent approval and launch, and what it means for the future of biosimilars.
Celltrion has set out plans to market directly its subcutaneous version of infliximab in Europe. The firm has just received a nod that sets the stage for approval across the EU, albeit with more limited indications than the existing intravenous version.
Celltrion has begun a Phase III study with a subcutaneous version of its infliximab biosimilar in the US, after the FDA allowed it to skip Phase I and II trials based on approval data in Europe, enabling a lower development time and cost.