Celltrion Files Subcutaneous Infliximab In US – As Standalone BLA
‘Biobetter’ Submitted To FDA As Biologic Via 351(a) Pathway, Not As A Biosimilar
Executive Summary
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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