Hospira Presents Results for Remicade Biosimilar

Hospira has posted the results of two open-label extension studies of CT-P13 (infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis. The results were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego.

CT-P13, branded as Inflectra, was approved by the EMA in September 2013 as a biosimilar to reference product, Remicade (infliximab). Inflectra is not currently approved for use in the U.S. The objective of the open-label extension studies was to confirm long-term efficacy and safety of Inflectra in patients who had completed the original 54-week EU clinical studies and to investigate switching from the reference Remicade product to Inflectra.

In one study, 302 of 455 patients with rheumatoid arthritis who completed the Phase III PLANETRA study entered into the open-label extension phase. Of these, 158 were continuously treated with Inflectra (maintenance group) and 144 were switched from Remicade to Inflectra (switch group) for one additional year. The maintenance group and the switch group at weeks 78 and 102 were similar as measured by American College of Rheumatology (ACR) ACR20/50/70, DAS28-CRP, DAS28-ESR, EULAR-CRP, and EULAR-ESR response rates. Overall incidence of treatment-emergent adverse events (TEAE) was similar in both groups.

In the other study, 174 of 210 patients with ankylosing spondylitis who completed the Phase I PLANETAS study entered into the open-label extension phase. Of these, 88 were continuously treated with Inflectra (maintenance group) and 86 were switched from Remicade to Inflectra (switch group) for one additional year. The maintenance group and the switch group at weeks 78 and 102 were similar as measured by ASAS20/ASAS40, ASAS partial remission, and ASDAS-CRP rates. In this study, the adverse event profile for CT-P13 was generally consistent with the originator.

Hospira is co-developing and marketing Inflectra with Celltrion, which is developing eight monoclonal antibody biosimilars. Hospira has the rights to Inflectra in Europe and certain CIS (Commonwealth of Independent States) countries, the U.S., Canada, Australia and New Zealand. Inflectra will be launched throughout Europe at the earliest opportunity, taking into account any relevant patent protection.