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and patients [ 56 ]. In the case of infliximab, for example, the proper name in the case
of CT-P13 per the FDA naming system is “infliximab-dyyb [ 44 ].”
The American Gastroenterological Association has conducted a survey of 180
members; 91% of respondents noted that they prescribe biologic agents in their
clinical practice, with the majority stating the presence of clinical trial-based effi-
cacy data was a key factor in their biologic prescribing for the IBD patients.
Although the majority of respondents (72%) reported they would likely prescribe
biosimilars if available in the USA, 78% had concerns regarding the safety and
immunogenicity profiles of the biosimilars, and 67% were opposed to indication
extrapolation for biosimilars in IBD [ 57 ]. The consensus across gastroenterology
societies, providers, and authorization agencies supports the role of biosimilars for
use in the IBD setting with the potential costsavings and increased accessibility
across multiple patient groups throughout the world. However, the need for more
IBD-centric biosimilar data is consistently emphasized as necessary prior to accep-
tance for routine clinical practice due to the unique complexities of the disease
states and patient populations.
Economic Considerations of Biosimilars
The cost of care of the IBD patient is substantial, and, for many patients, the costs
of therapy are rate-limiting factors that ultimately deny patient access to biologic
therapies. The annual estimated direct costs for CD patients, not on anti-TNF ther-
apy, range up to $18,000/year with approximately $11–15 billion in total economic
burden [ 58 ]. The annual estimated direct costs for UC patients, not on anti-TNF
therapy,are up to $11,000/year with approximately $5–9 billion total economic bur-
den [ 59 ]. Although the initiation of anti-TNF-α therapies has demonstrated cost-
effectiveness and increased quality-associated life-years compared to the
non-biologic-based standard of care therapies, the per-person costs are still signifi-
cant [ 60 , 61 ]. Remicade® sales globally were over 9.2 billion across the multiple
indications in 2014 [ 62 ]. In the COIN study performed in the Netherlands, anti-
TNF- α therapies accounted for 64% of total costs for CD and 31% of total costs for
UC patients, more than hospitalizations or surgeries, which were the primary driv-
ers for high IBD costs of care in the past [ 63 ]. Within the EpiCom IBD cohort of
close to 1400 IBD patients in Europe, of the total expenditures of almost $6 million,
biologic agents accounted for 14% following diagnostic evaluations (38%), surgery
(26%), and non-biologic-based treatment (22%) [ 64 ].
The intent ofthe congress with the creation of the BPCIA of 2009 was to allow
the FDA to create an abbreviatedprocess to expedite the introduction of biosimilars
to the market as branded biologics patent approach expiration [ 65 ]. Compared to
generic medications which cost on average $1–4 million to develop and new bio-
logic medications with an estimated $1.9 billion cost to develop and less than 10%
of agents successfully introduced into the market, the biosimilars cost between
$100–250 million to produce and take approximately 7–8 years before available for
C.Y. Ha and A. Kornbluth