Celltrion Files Subcutaneous Infliximab In US – As Standalone BLA

‘Biobetter’ Submitted To FDA As Biologic Via 351(a) Pathway, Not As A Biosimilar

 
• By Dave Wallace

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.

FDA building.
Celltrion has filed its subcutaneous infliximab with the FDA • Source: Shutterstock

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