State-level legislation on follow-on biologic substitution

Benedict, Adriana Lee

doi:10.1093/jlb/lsu005

Journal of Law and the Biosciences

2014

DOI: 10.1093/jlb/lsu005

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State-level legislation on follow-on biologic substitution

Adriana Lee Benedict¹

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Biosimilars in IBD: from theory to practice

Danese

Bonovas

Peyrin–Biroulet

2016

Nat Rev Gastroenterol Hepatol

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Biologic agents have revolutionized the care management of many life-threatening and debilitating diseases. As patents for older biologic therapies have begun to expire, the market has opened to copy versions of the originators - commonly referred to as biosimilars, follow-on biologic agents or subsequent-entry biologic agents - which are expected to gain a portion of the market, reduce health-care spending and increase treatment access worldwide. Importantly for patients with IBD, CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the European Medicines Agency in September 2013 and by the FDA in April 2016. In May 2016, SB2 was the second biosimilar to infliximab receiving marketing authorization in Europe. Currently, >20 other biosimilars to infliximab and adalimumab are in the development pipeline. Their similar-but-not-identical nature, and the concept of extrapolating efficacy and safety data from one therapeutic indication to another, seem to be confusing to physicians and cause concerns about the efficacy and safety of biosimilar products. A relevant debate is still ongoing in the field of IBD. This Review discusses the scientific principles underlying the biosimilar concept established in Europe and the USA, and discusses the current state of knowledge on biosimilar use in IBD.

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Biosimilars in IBD: from theory to practice

Danese

Bonovas

Peyrin–Biroulet

2016

Nat Rev Gastroenterol Hepatol

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State-level legislation on follow-on biologic substitution

Cited by 1 publication

References 0 publications

Biosimilars in IBD: from theory to practice

Biosimilars in IBD: from theory to practice

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