Celltrion Will Sell World's First Subcutaneous Infliximab Directly In Europe
Executive Summary
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.
You may also be interested in...
Celltrion Enlists Lonza To Help Make Its Remsima
Lonza will help Celltrion to satisfy increasing global demand for biosimilar infliximab after signing a deal to manufacture the drug substance for Remsima.
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.
Celltrion Begins US Phase III For Infliximab SC, Aims For 2022 Launch
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.