Establishing clinical equivalence

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PHASE l CLINICAL STUDY

STUDY DESlGN

N=138

Baseline to
Week 7

Phase l, randomised, three-arm, parallel-group, PK study comparing SC BenepaliTM (50 mg) with EU-and US-sourced rETN (50 mg) in healthy male volunteers

ADL concentrations were determined using ELISA. PK endpoints were: AUCinf, AUClast and Cmax. Safety and immunogenicity

Abbreviations: rADL, reference adalimumab; ELISA, enzyme linked immunosorbent assay; PK, pharmacokinetics; SC, subcutaneous.

REFERENCES

Benepali™ pharmacokinetics mirrored those of reference adalimumab1

Adapted from: Lee YJ, et al. 2016.

 

Adapted from: Emery P, et al. 2017.

Abbreviations: oETN, originator etanercept.