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A Randomized, Double-Blind, Efficacy and Safety Study of PF 05280586 (a Rituximab Biosimilar) Compared With Rituximab Reference Product (MabThera®) in Subjects With Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)

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posted on 16.01.2020 by Jeff P Sharman, Anna Marina Liberati, Kenichi Ishizawa, Tahira Khan, Jeffery Robbins, Ann Alcasid, Julie Ann Rosenberg, Igor Aurer

Plain language summary (PLS)

This Figshare page contains a plain language summary for Sharman et al's manuscript published in BioDrugs.


Disclaimers

- This study was sponsored by Pfizer.

- The rituximab biosimilar, PF-05280586, is not approved to treat the condition under study that is discussed in this summary. The originator version of rituximab is approved to treat the condition under study that is discussed in this summary.

- Researchers need to generate data and conduct one or more studies to show that biosimilars have a similar safety profile and are as effective as the originator products, with the same expected benefits and risks for people who receive them.

- This summary reports the results of only one study. The results of this study might be different from the results of other studies that the researchers look at.


Who sponsored these studies?

The work was sponsored by Pfizer Inc, New York, NY, USA. The sponsors would like to thank everyone who took part in this study.


Further information

Further information on the clinical trial can be found here: https://clinicaltrials.gov/ct2/show/NCT02213263


The study started in September 2014 and ended in April 2018.


Writing support

Plain language summary writing support was provided by Chu Kong Liew PhD, CMPP, Envision Pharma Group and funded by Pfizer Inc. The original authors of the full article were involved in preparing this summary.

Funding

Pfizer Inc.

History

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