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With Inflectra, FDA Showed Flexibility On Biosimilar Pediatric Study Plans

 
• By Sue Sutter

Drug Review Profile: Agency reviewed Celltrion's application while also negotiating an initial Pediatric Study Plan, and it crafted an exemption so that Inflectra and other biosimilars will not need to be studied in Crohn's disease patients as young as two years old.

In its review and approval of Celltrion Inc.'s biosimilar product Inflectra (infliximab-dyyb), FDA showed a willingness to be flexible on pediatric study issues likely to arise again as more products move through the nascent 351(k) regulatory pathway.

FDA resisted taking a hard line on Celltrion's belated submission of an initial Pediatric Study Plan (iPSP), the timing of which could have endangered the filing prospects for its application seeking approval as a biosimilar to

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