EMA Committee Recommends Approval for Celltrion’s Truxima (rituximab) Biosimilar

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to Celltrion’s Truxima (rituximab), a biosimilar to Roche’s Mabtherba, which is indicated for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Truxima marks just the second recommended approval by the CHMP this year—Biogen’s Flixabi (infliximab) biosimilar was recommended for approval in April 2016.  The CHMP has not issued a negative recommendation in 2016, although a number of applications have been withdrawn before an opinion was issued.

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