Head-to-head evidence
CT-P10 vs HLX01
Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.
Rheumatoid Arthritis
Shared mechanism: CD20 · full Rheumatoid Arthritis pipeline
CT-P10
Developed by Celltrion
NCT02149121 · Phase 3 · completed
This was a randomized, quadruple-blind, active-controlled trial with an adequately sized population (384 enrolled) that pre-specified formal equivalence margins for both its pharmacokinetic and its clinical disease-activity (DAS28-CRP) primary endpoints, and every comparison landed entirely within the required margin, meaning the biosimilar demonstrated therapeutic equivalence to the reference product on a validated hard clinical measure of rheumatoid arthritis activity, not just a proxy lab value.
HLX01
Developed by Shanghai Henlius Biotech
NCT03522415 · Phase 3 · completed
This randomised, quadruple-blind trial compared HLX01 plus methotrexate with placebo plus methotrexate in 275 patients with rheumatoid arthritis. At 24 weeks, 60.7% of patients on HLX01 reached an ACR20 response against 35.9% on placebo (P<0.001), a clear result on a validated measure of disease activity.
The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: CT-P10's landscape · HLX01's landscape