First US approval for biosimiliar non-Hodgkin's lymphoma therapy

29 November 2018
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The US regulator has approved the biosimilar Truxima (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL).

The approval allows the therapy, a biosimilar version of Roche’s (ROG: SIX) Rituxan (rituximab), to be marketed for use as a single agent or in combination with chemotherapy.

Developed by South Korean firm Celltrion Healthcare (Kosdaq: 068270), Truxima became the first biosimilar monoclonal antibody approved in an oncology indication anywhere, when it was given the green light in Europe at the start of 2017.

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