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Potential biosimilar to infliximab from Pfizer demonstrated efficacy similar to Remicade
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Pfizer Inc. announced its biosimilar to infliximab demonstrated efficacy similar to Remicade at week 14 in a phase 3 trial, according to a company press release.
In the REFLECTIONS phase 3 trial, researchers compared PF-06438179 (infliximab, Pfizer) with Remicade (Janssen Biotech Inc., infliximab) in combination with methotrexate for patients with moderate to severely active rheumatoid arthritis who had an inadequate response to methotrexate treatment alone. In the trial, Pfizer’s infliximab demonstrated equivalent efficacy as measured by ACR20 response at week 14.
REFLECTIONS will also evaluate the clinical response, safety and immunogenicity of transitioning from Janssen’s infliximab to Pfizer’s biosimilar following 30 weeks or 54 weeks of treatment with the Janssen drug.
PF-06438179 is a chimeric human-murine monoclonal antibody targeted against tumor necrosis factor. Researchers are developing PF-06438179 as a potential biosimilar to Remicade, which is approved in the United States and Europe to treat patients with rheumatoid arthritis.
In February 2016, Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 28 countries that comprise the European Economic Area (EEA). Pfizer still maintains rights to PF-06438179 outside of the EEA.
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