LAKE FOREST, Ill. — A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.
Hospira announced the results of two extension studies of Inflectra (infliximab), its biosimilar version of Johnson & Johnson's Remicade, in patients with rheumatoid arthritis and ankylosing spondylitis, at the American College of Rheumatology and Association of Rheumatology Health Professionals joint annual meeting in San Diego. The rheumatoid arthritis study included 302 patients, out of the 455 who had completed a previous clinical trial, while the ankylosing spondylitis study included 174 patients from a previous 210-patient trial.
In each study, participants were divided roughly in half, with one group receiving Inflectra continuously and one switching from Remicade to Inflectra. Patients in both studies showed similar responses in terms of efficacy and safety, whether they took Inflectra only or switched to it.
"We're very pleased with the findings of the two-year extension studies," Hospira corporate VP and chief medical officer Stan Bukofzer said. "We are committed to continuing to build on our biosimilars experience."
Inflectra, which Hospira also refers to as CT-P13, was approved in the European Union in September, though it is not approved in the United States. A provision of the Patient Protection and Affordable Care Act included an abbreviated regulatory approval pathway for biosimilars, though Food and Drug Administration regulations have not yet been finalized. Biosimilars are expected to reach the U.S. market in the middle of the decade.