Rituximab biosimilar TRUXIMA® approved by the EMA for use in CLL and NHL

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

This approval comes after the Positive Opinion given by the Committee of Medicinal Products for Human Use (CHMP), which the Lymphoma Hub reported on in January 2017.

Looking ahead, Celltrion is preparing to file TRUXIMA® in the US, selecting Teva as its commercial partner for the US and Canada.1

  1. Pharmaphorum. Truxima, world’s first cancer drug biosimilar approved in Europe. 2017 Feb 22. [Accessed 2017 Feb 28].
  2. eMC. Mabthera 100mg and 500mg Concentrate for Solution for Infusion SPC. 2016 Jun 08. Accessed 2017 Feb 28.
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