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Rituximab Biosimilar Succeeds in Phase III Follicular Lymphoma Trial

Jason Harris
Published: Wednesday, Jan 24, 2018

PF-05280586, a biosimilar for rituximab (Rituxan/MabThera), delivered positive top-line results in the phase III REFLECTIONS B3281006 follicular lymphoma (FL) trial, meeting its primary endpoint for overall response rate (ORR).

In September 2017, the FDA accepted a biologics license application for the rituximab biosimilar Rixathon (GP2013), which is manufactured by Sandoz (Novartis). Also in September 2017, the FDA approved ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin), as the first FDA-approved biosimilar for the treatment of patients with cancer. In December 2017, the FDA approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst).
  1. FDA Approves Two New Indications for Rituxan in Patients With Non-Hodgkin's Lymphoma. Genentech. Published: September 29, 2006. Accessed: January 24, 2018.
  2. Rituximab Full Prescribing Information. Accessed: January 24, 2018.

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TitleExpiration DateCME Credits
Medical Crossfire®: Addressing Uncertainties in Oncology BiosimilarsApr 30, 20201.5
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