News about GMP/cGMP


FDA: Approvement of Second Biosimilar

The US Food and Drug Administration (FDA) approved a second biosimilar, Inflectra (infliximab-dyyb), biosimilar to Janssen Biotech’s arthritis treatment Remicade (infliximab). Inflectra, coming from Celltrion and Pfizer, is a monocional antibody biosimilar. The European Medicines Agency already approved Celltrion’s Remicade biosimilar in 2013. Other countries that already gave their approval are Canada, Japan and Korea.

This is considered to be a big step forward for biosimilars in the US as it sends a signal that the FDA has confidence in the approval process and the review of more complex biosimilars. 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.

The FDA points out that Inflectra has been approved as biosimilar, not as an interchangeable product. According to FDA, biosimilar means that "the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product". The approval is also noteworthy for FDA’s decision to follow some precepts that the Agency decreed in recent draft biosimilar guidances, including:

  1. requiring that Inflectra’s prescribing information identifying it as a biosimilar of Remicade
  2. Inflectra being given a product name with a meaningless four syllable suffix (“infliximab-dyyb”); and
  3. the prescribing information including four different means of product identification (“Inflectra,” “Remicade,” “infliximab-dyyb” and “infliximab”) as appropriate to the circumstances.

Inflectra is manufactured by Celltrion, Inc, based in Yeonsu-gu, Republic of Korea. The facilities where biosimilars are manufactured must also meet the FDA’s standards.


FDA: Press Announcement



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