First Biosimilar MabThera One Step Away from EU Approval; Pegfilgrastim Filings Withdrawn

If the European Commission follows the recommendation of the European Medicines Agency and approves Celltrion’s Truxima (rituximab), the product will become the first biosimilar version of Roche’s cancer drug MabThera to reach the EU market. It’s good news for Celltrion, but that’s not the case for Gedeon Richter, whose approval applications for Cavoley and Efgratin – biosimilar versions of Amgen’s Neulasta (pegfilgrastim) – have been withdrawn.

Truxima has received a positive opinion from the EMA’s scientific committee, the CHMP, for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis