Comparative Clinical Efficacy and Safety of the Proposed Biosimilar ABP 710 With Infliximab Reference Product in Patients With Rheumatoid Arthritis

Mark C. Genovese; Juan Sanchez-Burson; MyungShin Oh; Eva Balazs; Jeffrey Neal; Andrea Everding; Tomas Hala; Rafal Wojciechowski; Gary Fanjiang; Stanley Cohen

Disclosures

Arthritis Res Ther. 2020;22(60) 

In This Article

Conclusions

In conclusion, this randomized, double-blind, active-controlled, multiple-dose, comparative clinical study showed that there were no clinically meaningful differences between ABP 710 and infliximab RP. In addition, this study demonstrated that the safety and immunogenicity of ABP 710 were similar to those of the RP and that efficacy and safety were not impacted by a single switch from infliximab RP to ABP 710. These results, along with the totality of evidence, which includes demonstration of similarity of ABP 710 with the infliximab RP in analytical assessments and PK and safety evaluation in healthy patients, confirm that ABP 710 is similar to infliximab RP.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

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