Insights on the use of biosimilars in the treatment of inflammatory bowel disease

Table 1 Comparison of biologics and biosimilars

	Biologics	Biosimilars
Development costs[26,103]	Approximately $2 billion	Approximately $100-250 million
Characterization	Exhibits heterogeneity	Exhibits heterogeneity
Patent duration	20 yr; up to 12-yr exclusivity period	No patent licensing
Approval process	Submission of a BLA	Submission of an aBLA
Immunogenicity	Possible risk	Possible risk
Indication extrapolation	Not permitted	Case-by-case basis

aBLA: Abbreviated biologics license application; BLA: Biologics license application.