The challenge of indication extrapolation for infliximab biosimilars

Author:

Feagan Brian G.,Choquette Denis,Ghosh Subrata,Gladman Dafna D.,Ho Vincent,Meibohm Bernd,Zou Guangyong,Xu Zhenhua,Shankar Gopi,Sealey David C.,Russell Anthony S.

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference59 articles.

1. Development and regulation of biosimilars: current status and future challenges;Tsiftsoglou;BioDrugs,2013

2. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues;Committee for Medicinal Products for Human Use, European Medicines Agency,2012

3. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs);Health Products and Food Branch, Health Canada,2010

4. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product (draft guidance);U.S. Food and Drug Administration,2012

5. Guidelines on evaluation of similar biotherapeutic products;Expert Committee on Biological Standardization, World Health Organization,2009

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