Table 2

Key study design elements for adalimumab biosimilar studies in rheumatoid arthritis*

CompanyAmgenBoehringer IngelheimFuji Film Kyowa Kirin BiologicsPfizerSamsung Bioepis
DrugABP-501BI 695501FKB327PF-06410293SB5
Disease activity≥6 Swollen and ≥6 tender joints†. Acute reactant requirement not available≥6 Swollen and ≥6 tender joints. Either ESR of >28 mm/h or CRP>1.0 mg/dL≥6 Swollen and ≥6 tender joints
CRP≥1.0 mg/dL
≥6 Swollen and ≥6 tender joints
hs-CRP≥0.8 mg/dL
≥6 Swollen and ≥6 tender joints
Either ESR≥28 mm/h or CRP≥1.0 mg/dL
Previous biological therapyPermitted (<2 agents)Permitted (<2 agents)Permitted (<2 agents)Not permitted‡Not permitted
MTX treatmentRequired
Stable dose of 7.5–25 mg/week
Stable dose of 15–25 mg/week§
Stable dose of 10–25 mg/week
Dose range not available
Stable dose of 10–25 mg/week
Transition design¶At week 26, single-arm OLE with ABP-501Transition from Humira to either Humira or BI695501 after week 24Transition after week 24 in separate OLE with two arms, including Humira and FKB327. After week 52, all patients receive open-label FKB327At week 26, Humira arm rerandomised to either Humira or PF-06410293. At week 52, all patients receive open-label PF-06410293**Transition from Humira to either SB5 or Humira after week 24
Primary end pointACR20 at week 24Coprimary: ACR20 at week 24 and at week 12ACR20 at week 24ACR20 at week 12ACR20 at week 24
  • *Unless specified otherwise, study design information is summarised on the basis of information from the or EU clinical trial registry (see table 1 for NCT or EudraCT number), searched on 8 September 2015. All studies included in table 2 have an equivalence design.

  • †From the 66/68 count system.

  • ‡No more than two doses of one biological therapy (other than adalimumab or a lymphocyte depleting therapy).

  • §Dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose.

  • ¶Transition from the branded to the biosimilar product within the main study or in the OLE study.

  • **Study design information from the Peru clinical trial registry, based on a search of biosimilar adalimumab in Citeline's Trialtrove database on 8 September 2015.

  • ACR20, 20% improvement in the American College of Rheumatology criteria; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; EU, European Union; hs-CRP, high-sensitivity CRP; MTX, methotrexate; OLE, open-label extension.