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)-Reference-Cited by-同舟云学术

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)

Published:2019-12-09 Issue:2 Volume:34 Page:171-181
ISSN:1173-8804
Container-title:BioDrugs
language:en
Short-container-title:BioDrugs

Author:

Sharman Jeff P.,Liberati Anna Marina,Ishizawa Kenichi,Khan Tahira,Robbins Jeffery,Alcasid Ann,Rosenberg Julie Ann,Aurer Igor

Funder

Pfizer

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Link

http://link.springer.com/content/pdf/10.1007/s40259-019-00398-7.pdf

Reference25 articles.

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2. European Medicines Agency. Guideline on similar biological medicinal products. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed 9 Jan 2019.

3. Baer WH II, Maini A, Jacobs I. Barriers to the access and use of rituximab in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia: a physician survey. Pharmaceuticals (Basel). 2014;7(5):530–44.

4. IMS. Delivering on the potential of biosimilar medicines: the role of functioning competitive markets. 2016. https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf. Accessed 9 Jan 2019.

5. Hoffmann-La Roche Ltd. MabThera (rituximab) summary of product characteristics. London. 2009. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000165/WC500025821.pdf. Accessed 9 Jan 2019.

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