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Celltrion Data Supports Subcutaneous Remisma For IBD

Also Backs Biosimilar For Crohn’s Disease And Ulcerative Colitis

Executive Summary

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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Podcast: Celltrion’s Subcutaneous Infliximab And The Future Of Biosimilars

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 Will Market Subcutaneous Remsima Directly After EU Nod

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 Begins US Phase III Trial For Subcutaneous Infliximab

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.

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