Celltrion's Truxima wins FDA interchangeability designation

Celltrion said Wednesday that its blood cancer treatment Truxima received interchangeability designation from the US Food and Drug Administration, becoming the first biosimilar version of rituximab to secure the status and its associated exclusivity period.

Truxima is approved in the US for all adult indications held by its reference biologic, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis and microscopic polyangiitis.

The FDA's interchangeability designation ...