First Biosimilar in Oncology, Truxima, Granted Marketing Approval in European Union

We previously reported that the Committee for Medicinal Products for Human Use (CHMP) had recommended that the European Medicine Agency (EMA) grant marketing approval for Truxima (CT-P10), Celltrion Healthcare’s biosimilar of Roche’s monoclonal antibody product MabThera (rituximab). Last week, the EMA authorized Truxima for all the approved therapeutic indications of MabThera, making it the first biosimilar for a cancer indication in Europe. In a press release, Celltrion cited data from Professor László Gulácsi, head of the department of health economics at Corvinus University of Budapest, who estimated that the drug might save 570 million euros across 28 member states over the next three years.

For further developments, stay tuned to Big Molecule Watch.