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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
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In your experience, what is the average vein-to-vein time when treating patients with DLBCL with a reimbursed CAR T-cell therapy (from apheresis to infusion)?