Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab)-Reference-Cited by-同舟云学术

Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab)

Published:2016-09-01 Issue:11 Volume:33 Page:1964-1982
ISSN:0741-238X
Container-title:Advances in Therapy
language:en
Short-container-title:Adv Ther

Author:

Derzi Mazin,Johnson Theodore R.,Shoieb Ahmed M.,Conlon Hugh D.,Sharpe Penny,Saati Andrew,Koob Sarah,Bolt Michael W.,Lorello Leslie G.,McNally Jim,Kirchhoff Carol F.,Smolarek Teresa A.,Leach Michael W.

Funder

Pfizer

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),General Medicine

Link

http://link.springer.com/content/pdf/10.1007/s12325-016-0403-9.pdf

Reference21 articles.

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2. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. 2015. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf . Accessed 1 May 2015.

3. World Health Organization, Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf . Accessed 4 Feb 2015.

4. European Medicines Agency. Guideline on similar biological medicinal products. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf . Accessed 14 April 2015.

5. Janssen Biotech Inc. Remicade® (infliximab) prescribing information. 2015. http://www.remicade.com/shared/product/remicade/prescribing-information.pdf . Accessed Sept 21 2015.

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