Table 2

Study designs for biosimilar switching: June 2019

Bio-originator/biosimilarStudy design (phase)IndicationType of switch
Infliximab/CT-P13 (PLANETRA)OL extension of DB RCTRAOne way, bo→bs
Infliximab/CT-P13 (PLANETAS)OL extension of DB RCTASOne way, bo→bs
Infliximab/CT-P13Observational single-centre studyRA, SpA, PsA, JIA, chronic reactive arthritisOne way, bo→bs
Infliximab/CT-P13Observational registryRA, SpA, PsA, other (not defined)One way, bo→bs
Infliximab/SB2DB RCTRAOne way, bo→bs
Infliximab/biosimilarRetrospective single-centre studyInflammatory arthritisOne way, bo→bs
Infliximab/biosimilarMulti-centre studyAS, PsA, SpA, enteropathic arthritisOne way, bo→bs
Etanercept/SB4SB crossover-One way, bo→bs; bs→bo
Etanercept/SB4OL extension of DB RCTRAOne way, bo→bs
Etanercept/GP2015Two-way crossoverOne way, bo→bs; bs→bo
Adalimumab/SB5DB RCTRAOne way, bo→bs
Rituximab/CT-P10OL extension of RCTRAOne way, bo→bs
  • AS, ankylosing spondylitis; bo, biologic originator; bs, biosimilar; DB, double blind; JIA, juvenile idiopathic arthritis; OL, open label; PsA, psoriatic arthritis; RA, rheumatoid arthritis; RCT, randomised controlled trial; SB, single blind; SpA, spondyloarthritis.