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Inflectra Label Not Exactly Silent On Remicade's Orphan-Protected Claim

 
• By Sue Sutter

Although FDA did not approve the biosimilar for pediatric ulcerative colitis, Inflectra labeling states that a pediatric assessment demonstrates it is 'safe and effective in another pediatric indication.'

FDA's treatment of an orphan-protected Remicade indication in the labeling for Celltrion Inc.'s biosimilar Inflectra may stir some controversy.

While Inflectra's approved labeling does not include an indication for pediatric ulcerative colitis, an orphan-protected use on the labeling of Janssen Biotech Inc

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