273Interchangeability
In January 2017, the FDA issued theirguidance document regarding the critical
issue ofinterchangeability, whereby an approved biosimilar can be substituted for a
prescribed reference drug without the approval or even the knowledge of the pre-
scribing physician or patient [ 45 ]. Beyond demonstrating biosimilarity, the sponsor
the biosimilar may request a claim of “interchangeability.” According to FDA draft
guidance in May 2015, the approval of interchangeability allows that the biosimilar
“may be substituted for the reference product without the intervention of the pre-
scribing healthcare provider” [ 46 ]. In theJanuary 2017 FDA guidance document,
the FDA defined the weight of evidence to fulfill the “higher-level” requirement that
an interchangeable product “can be expected to produce the same clinical result as
the reference product, in any given patient and the risk in terms of safety or dimin-
ished efficacy of alternating or switching between the use of the biologic product
and the reference product is not greater that the risk of using the reference product
without such alternation or switch” [ 46 ]. This has become a particularly contentious
issue that has been legislated in the USA on a state-by-state basis (Fig.15.4). More
specifically, the FDA did not grant interchangeability of CT-P13 with reference inf-
liximab when it approved CT-P13 in April 2016, nor did it grant interchangeability
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DCAS GU MP VI PRRI© 2016 NCSL - Updated 11/15/2016
See NCSL reports for details at http://www.ncsl.orgLegislation on Biologics and Biosimilar Substitution, 2013-2016Fig.15.4 Biosimilar legislation throughout the USA. Source: State laws and legislation related to
biologic medications and substitution of biosimilars. http://www.ncsl.org/research/health/state-
laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx [ 76 ]
15 Biosimilars in Inflammatory Bowel Disease 2017: State of the Science