Biosimilar Remsima/Inflectra matches efficacy of Remicade in Ankylosing Spondylitis - Hospira

Hospira has announced data showing that the 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 Ankylosing Spondylitis (AS). The data comprise secondary endpoints of the PLANETAS study in which Inflectra was shown to be comparable to Remicade in terms of secondary endpoints reducing disease activity, relieving disability and improving mobility in people with AS after 54 weeks.

Overall no statistical difference in clinical responses was observed between the two treatment groups. Disease activity was measured via the Assessment in Ankylosing Spondylitis International Working Group criteria and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The study measured disability via the Bath Ankylosing Spondylitis Functional Index (BASFI) and mobility via the Bath Ankylosing Spondylitis Metrology Index (BASMI).

Overall, the type and incidence of adverse events reported with Inflectra and Remicade appeared generally similar to the type and incidence of adverse events reported in the European product label for Remicade. The results were shared at the European League Against Rheumatism (EULAR) congress.