On 22nd February 2017, the European Medicines Agency (EMA) approved TRUXIMA® for use in all indications of the reference product (Roche’s MabThera®): including FL, DLBCL, and CLL.1,2
Celltrion’s TRUXIMA® is the first monoclonal antibody biosimilar that has been approved in Europe for the treatment of cancer. Mundipharma, and its network of independent associated companies, has distribution rights for 7 European countries: UK, Germany, Italy, Ireland, Belgium, Luxembourg, and the Netherlands.
TRUXIMA® is expected to be less expensive than MabThera®.1
Looking ahead, Celltrion is preparing to file TRUXIMA® in the US, selecting Teva as its commercial partner for the US and Canada.1
- Pharmaphorum. Truxima, world’s first cancer drug biosimilar approved in Europe. 2017 Feb 22. http://pharmaphorum.com/news/roche-mabthera-faces-cheaper-rival-eu/. [Accessed 2017 Feb 28].
- eMC. Mabthera 100mg and 500mg Concentrate for Solution for Infusion SPC. 2016 Jun 08. https://www.medicines.org.uk/emc/medicine/2570. Accessed 2017 Feb 28.