1. Generics Bulletin

Celltrion’s Rituximab Biosimilar Is The First Greenlit By The FDA

 
• By Dean Rudge

Truxima (rituximab-abbs) becomes the first biosimilar to Rituxan approved by the US agency, although launch timing remains unclear; Celltrion also has novel infliximab subcutaneous formulation accepted for review by the EMA.

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FDA gives Truxima the green light

The first biosimilar with non-Hodgkin’s lymphoma (NHL) indications, Celltrion’s Truxima (rituximab-abbs), has passed the US Food and Drug Administration (FDA) approval process, becoming also the first Rituxan (rituximab) biosimilar authorised in the US.

Launch plans for Truxima remain unclear, for now

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