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FDA approves Ixifi, third Remicade biosimilar
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The FDA has approved the third biosimilar to infliximab, infliximab-qbtx, for all eligible indications of the biologic product, according to a company press release.
Ixifi (infliximab-qbtx, Pfizer), a biosimilar to Remicade (infliximab, Janssen), is a chimeric human-murine anti-tumor necrosis factor monoclonal antibody intended to treat patients with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
With this approval, Ixifi has become the third biosimilar to Remicade to launch in the United States, following Inflectra (infliximab-dyyb, Celltrion/Pfizer) in 2016 and Renflexis (infliximab-abda, Samsung and Merck) earlier this year.
The FDA based its approval on data from the phase 3 REFLECTIONS B537-02 trial, which evaluated the safety, efficacy and immunogenicity of Ixifi vs. Remicade in combination with methotrexate among patients with moderate to severely active rheumatoid arthritis who had an inadequate response to methotrexate treatment alone.
Results from the multi-national, randomized, double blind study demonstrated that Ixifi sustained equivalent efficacy to Remicade as measured by ≥20% improvement by American College of Rheumatology criteria at week 14.
Similar to the biologic product, Ixifi will include a boxed warning for increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections and infections resulting from other opportunistic pathogens.