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.

Table 2 Proposed anti-tumor necrosis factor biosimilars¹

Reference medicinal product	Biosimilar name
Infliximab	Infliximab-dyyb (Celltrion)2
	SB2 (Samsung Bioepis)
	PF-06438179 (Sandoz)
	BOW015 (Epirus)
Adalimumab	Adalimumab-atto (Amgen)2
	SB5 (Samsung Bioepis)
	ZRC-3197 (Zydus Cadila)
	MSB11022 (Merck KGaA)
Certolizumab pegol	PF688 (PFEnex)
Golimumab	BOW100 (Epirus)

¹Information for each biosimilar was derived from the website of its respective drug company;

²Approved by the United States Food and Drug Administration.

Table 3 Clinical studies on infliximab-dyyb induction in inflammatory bowel disease

Ref.	Study	Population	Results	Safety
Jahnsen et al[84]	Prospective observational	CD = 46; UC = 32	Clinical remission rate at week 14: 79% (CD), 56% (UC)	No adverse events reported
			Significant decrease in CRP, calprotectin
Jung et al[82]	Retrospective multicenter	CD = 32; UC = 42	Clinical response at week 54: 87.5% (CD), 100% (UC)	Adverse events in 11% of UC patients
			Clinical remission rate at week 54: 75% (CD), 50% (UC)
Gecse et al[85]	Prospective, multicenter, nationwide cohort	CD = 126; UC = 84	Clinical response at week 14: 81.4% (CD), 77.6% (UC)	Adverse events in 17.1% of all patients
			Clinical remission rate at week 14: 53.6% (CD), 58.6% (UC)
Murphy et al[81]	Descriptive	IBD = 36	CRP levels: increase in 93% of Inflectra patients, decrease in 100% of Remicade patients	29% increase in hospital readmission and 75% increase in surgery rates with Inflectra patients
		(Remicade = 22;
		Inflectra = 14)
Sieczkowska et al[86,104]	Switch from RMP to Infliximab-dyyb	Pediatric CD = 32; Pediatric UC = 7	Clinical remission rate: 88% (CD), 57% (UC)	No adverse events reported
			Decrease in PCDAI, CRP, ESR
Smits et al[87]	Prospective, observational, cohort switch	CD = 57; UC = 26	No significant change in DAI, CRP, calprotectin at week 16	No adverse events reported

CD: Crohn’s disease; CRP: C-reactive protein; DAI: Disease Activity Index; ESR: Erythrocyte sedimentation rate; HBI: Harvey-Bradshaw Index; IBD: Inflammatory bowel disease; PCDAI: Pediatric Crohn’s Disease Activity Index; UC: Ulcerative colitis.