Celltrion Files Subcutaneous Infliximab In US – As Standalone BLA
‘Biobetter’ Submitted To FDA As Biologic Via 351(a) Pathway, Not As A Biosimilar
Celltrion is seeking US approval for its subcutaneous formulation of infliximab, marketed in other territories as Remsima SC. The product will be registered as a standalone biologic rather than a biosimilar.
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Celltrion Opens Up Canadian Market For Remsima SC
Celltrion has pushed into another new market with its Remsima SC subcutaneous version of infliximab, launching the innovative biosimilar in Canada.
Celltrion’s Remsima SC Will No Longer Need IV Loading
Celltrion has received an endorsement from the European Medicines Agency that means that its Remsima SC subcutaneous formulation of infliximab can be used directly in rheumatoid arthritis patients, without the need for intravenous loading first.
Celltrion’s Remsima SC Biosimilar Starts Strong In EU5 Countries
Celltrion is capitalizing on the earlier strength of its intravenous Remsima formulation to make waves with its innovative subcutaneous version, according to the results of a new study sampling nearly 250 gastroenterologists in EU5 countries.