Inflectra Receives FDA Approval

The U.S. Food and Drug Administration has approved Inflectra for multiple indications, including rheumatoid arthritis (RA). As indicated in the April 5, 2016 news release, Inflectra is biosimilar to Horsham, Pennsylvania-based Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra, manufactured by Celltrion, Inc, based in Yeonsu-gu, Incheon, Republic of Korea, for Hospira, of Lake Forest, Illinois, is administered by intravenous infusion.

According to the news release, “Inflectra is approved and can be prescribed by a health care professional for the treatment of: adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease [CD] who have had an inadequate response to conventional therapy; adult patients with moderately to severely active ulcerative colitis [UC] who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis (arthritis of the spine); patients with active psoriatic arthritis [PsA]; adult patients with chronic severe plaque psoriasis [PsO]. The FDA’s approval of Inflectra is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Inflectra is biosimilar to Remicade. Inflectra has been approved as biosimilar, not as an interchangeable product.”

“Biosimilars can provide access to important treatment options for patients who need them, ” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, in the news release. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”

Eric J. Pahon, press officer for the FDA, told OTW, “The FDA’s approval of Inflectra is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Inflectra is highly similar to Remicade and that there are no clinically meaningful differences between Inflectra and Remicade.”

“Because the data submitted by Celltrion included a comparison of Inflectra to the European Union-approved Remicade, Celltrion scientifically justified the relevance of that data to a demonstration of biosimilarity to U.S.-licensed Remicade. Review of the scientific justification confirms the use of these data to support a demonstration that Inflectra is biosimilar to U.S.-licensed Remicade.”

“Celltrion also submitted extensive data and sufficient scientific justification to support extrapolation of data from comparative clinical studies in RA and AS to support a demonstration of biosimilarity for PsA, PsO, adult and pediatric CD and adult UC.”