The decision – which is in keeping with the European Medicines Agency’s (EMA) recommendation– makes the Truxima the first biosimilar monoclonal antibody (mAb) to be cleared as a cancer treatment anywhere in the world according to Celltrion.
Celltrion will make Truxima at its facility in Songdo, Korea where it produces all of its biosimilars. The facility is currently the focus of an expansion programme, the aim of which is to increase capacity to 310,000L by 2021.
Jung-Jin Seo, Chairman of Celltrion Group, said: “For healthcare systems burdened with high cost oncology treatments, we are pleased to provide an option that has the potential to offer significant savings whilst ensuring patients retain access to high-quality and effective treatments.”
The firm did not respond to a request for specific pricing information.
Truxima is the second Celltrion biosimilar approved in Europe after its product Remsima – a version of Johnson & Johnson’s Remicade (infliximab) – which was approved in 2013.
When Truxima was approved in Korea last year Celltrion said it planned to submit the drug to the US Food and Drug Administration (FDA) sometime this year.
If approved in the US Truxima will be sold by Teva Pharmaceutical Industries Ltd., which signed a $160m commercialization partnership with Celltrion last October.
A spokeswoman for Celltrion told us "Teva and Celltrion have entered into an exclusive partnership to commercialise Truxima in the US and Canada, and Mundipharma have distribution rights in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands."
She added that: "Truxima will be made available to patients from Q2 2017."