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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

Celltrion has pushed forward with plans to bring its novel subcutaneous version of infliximab to the US market, even if it means having to file the product via a standalone biologics license application rather than as a biosimilar.

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Generics Bulletin reviews global regulatory developments across the world.