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Inflectra Reviewers

Executive Summary

FDA staff who participated in the agency's review of Celltrion's infliximab-dyyb, a biosimilar to Janssen's Remicade.

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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.

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