Statement on the U.S. Food and Drug Administration (FDA) Approval of Celltrion’s Infliximab Biosimilar

Pfenex is pleased that the U.S. Food and Drug Administration (FDA) approved the second biosimilar in the U.S., Celltrion’s Inflectra™. Until today, this treatment—infliximab, which is used to treat rheumatoid arthritis and other inflammatory diseases–existed only as a branded biologic. The approval of a biosimilar product has the potential to provide thousands of patients across the nation with access to a more affordable and equally-effective alternative.


Further, the acknowledgement by the FDA that the data package provided by Celltrion was sufficient to address the scientific considerations for extrapolation across indications demonstrates the effectiveness of the biosimilars pathway as set forth in the Biologic Price Competition and Innovation Act. We applaud the FDA for taking this step and look forward to additional guidance to further facilitate the development of a robust biosimilars market in the U.S., with the potential to significantly reduce healthcare costs and increase patient access to life-changing treatments.