Mean primary outcome results (ACR20 for RA and PASI75 for Ps) for the 15 comparative efficacy trials performed on anti-TNFα biosimilars to date. Results are for the Per Protocol Set (PPS) except in the case of ABP 501 and AVT02 where data from Full Analysis Set is provided as PPS data were not available

ProductWeek that 1 endpoint measuredApproval
year
Biosimilar (B)
%
Ref. Product (R)
%
Response difference (B – R)
% (95% CI)
Infliximab: Studies in rheumatoid arthritis (N = 478–650; 1:1 randomization)
CT-P13 [2]Week 30201373.4%69.7%+3.7% (–0.04, 0.12)
SB2 [3]Week 30201664.1%66.0%–1.88% (–10.26, 6.51)
GP-11 [4]Week 14201866.7%67.2%–0.58% (–8.42, 7.23)
Etanercept: Studies in rheumatoid arthritis (N = 427–481; 1:1 randomization)
SB4 [5]Week 24201578.1%80.3%–2.2% (–9.41, 4.18)
YLB113 [7]Week 24202086.0%90.6%–4.6% (–10.1, 0.8)
Etanercept: Studies in psoriasis (N = 571; 1:1 randomization)
GP15 [6]Week 16201773.4%75.7%–2.3% (–9.85, 5.30)
Adalimumab: Studies in rheumatoid arthritis (N = 476–648; 1:1 randomization)
ABP 501 [8]Week 24201774.6%72.4%+2.604% (–4.941, 10.149)
SB5 [9]Week 24201772.4%72.2%+0.1% (−7.83, 8.13)
FKB327 [10]Week 24201879.3%79.7%–0.4% (–6.7, 5.9)
PF06410293 [13]Week 12202070.8%75.2%–4.41% (N/A)
CT-P17 [14]Week 24202087.0%87.0%+0.06% (–5.60, 5.78)
BI 69550 [17]Week 24201770.3%68.8%+1.6% (–6.6, 9.8)
Adalimumab: Studies in psoriasis (N = 393–441; 1:1 randomization)
GP2017 [11]Week 16201866.8%65.0%+1.8% (7.46, 11.15)
MSB2022 [15]Week 16201990%92%–1.86% (–7.82, 4.16)
AVT02 [16]Week 16202289.2%86.9%+2.3% (–1.34, 5.88)