Inflectra Clinical Development Timeline
Executive Summary
Chronicle of development and FDA review of Celltrion's biosimilar infliximab-dyyb.
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Inflectra Analytical Data Eased FDA's 'Residual Uncertainty' About Remicade Differences
Pink Sheet's Drug Review Profile reveals FDA's second biosimilar got hung up on product quality concerns that suggested potential differences between Celltrion's CT-P13 and its reference biologic, Janssen's infliximab.
Evolving Biosimilar Pathway Brings Mid-Review Policy Issues
Drug Review Profile: Labeling, unique fee structure among many challenges that Inflectra sponsor Celltrion and FDA had to navigate in nascent regulatory pathway.
Biosimilar Naming: FDA Asked Celltrion For Two Kinds Of Suffixes
Drug Review Profile: Inflectra sponsor submitted nonproprietary name suffixes that were both devoid of meaning and meaningful; agency concluded nonmeaningful suffix "-dyyb" was unlikely to be source of error.