Biosimilar Remsima/Inflectra shows comparable efficacy to Remicade in Rheumatoid Arthritis trial - Hospira

Hospira has announced data showing that biosimilar monoclonal antibody Remsima/Inflectra (infliximab) demonstrated comparable and sustained reductions in disease activity to European reference product Remicade over one year in patients with Rheumatoid Arthritis. Inflectra is the first biosimilar monoclonal antibody to be approved in Europe as an alternative to Remicade.

The data comprise secondary endpoints of the PLANETRA study of nearly 500 patients. Inflectra was shown to be comparable to Remicade across a range of primary and secondary efficacy endpoints in RA after 54 weeks, including mean decrease in Disease Activity Score 28, Clinical Disease Activity Index (CDAI; -25.7 with Inflectra and -24.0 with Remicade), and Simplified Disease Activity Index (SDAI; -26.3 with Inflectra and -24.6 with Remicade).

The effect of anti-drug antibody was also measured and the degree of change in the ADA positive versus negative populations was the same in both treatment groups. Overall, no statistical difference in clinical responses was observed between the two treatment groups. Data for these endpoints have been previously reported at week 30. The results were presentedat the European League Against Rheumatism (EULAR) congress.