The challenge of indication extrapolation for infliximab biosimilars

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

Research output: Contribution to journalReview article

94 Citations (Scopus)

Abstract

A biosimilar is intended to be highly similar to a reference biologic such that any differences in quality attributes (i.e., molecular characteristics) do not affect safety or efficacy. Achieving this benchmark for biologics, especially large glycoproteins such as monoclonal antibodies, is challenging given their complex structure and manufacturing. Regulatory guidance on biosimilars issued by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency indicates that, in addition to a demonstration of a high degree of similarity in quality attributes, a reduced number of nonclinical and clinical comparative studies can be sufficient for approval. Following a tiered approach, clinical studies are required to address concerns about possible clinically significant differences that remain after laboratory and nonclinical evaluations. Consequently, a critical question arises: can clinical studies that satisfy concerns regarding safety and efficacy in one condition support "indication extrapolation" to other conditions? This question will be addressed by reviewing the case of a biosimilar to infliximab that was approved recently in South Korea, Europe, and Canada for multiple indications through extrapolation. The principles discussed should also apply to biosimilars of other monoclonal antibodies that are approved to treat multiple distinct conditions.

Original languageEnglish (US)
Pages (from-to)177-183
Number of pages7
JournalBiologicals
Volume42
Issue number4
DOIs
StatePublished - Jan 1 2014

Fingerprint

Biosimilar Pharmaceuticals
Monoclonal antibodies
Extrapolation
Glycoproteins
Medicine
Canada
Demonstrations
Monoclonal Antibodies
Health
Safety
Benchmarking
Republic of Korea
United States Food and Drug Administration
Biological Products
Infliximab
Clinical Studies

All Science Journal Classification (ASJC) codes

  • Biotechnology
  • Bioengineering
  • Applied Microbiology and Biotechnology
  • Immunology and Microbiology(all)
  • Pharmacology

Cite this

Feagan, B. G., Choquette, D., Ghosh, S., Gladman, D. D., Ho, V., Meibohm, B., ... Russell, A. S. (2014). The challenge of indication extrapolation for infliximab biosimilars. Biologicals, 42(4), 177-183. https://doi.org/10.1016/j.biologicals.2014.05.005

The challenge of indication extrapolation for infliximab biosimilars. / 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.

In: Biologicals, Vol. 42, No. 4, 01.01.2014, p. 177-183.

Research output: Contribution to journalReview article

Feagan, BG, Choquette, D, Ghosh, S, Gladman, DD, Ho, V, Meibohm, B, Zou, G, Xu, Z, Shankar, G, Sealey, DC & Russell, AS 2014, 'The challenge of indication extrapolation for infliximab biosimilars', Biologicals, vol. 42, no. 4, pp. 177-183. https://doi.org/10.1016/j.biologicals.2014.05.005
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. / The challenge of indication extrapolation for infliximab biosimilars. In: Biologicals. 2014 ; Vol. 42, No. 4. pp. 177-183.
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