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Evolving Biosimilar Pathway Brings Mid-Review Policy Issues

Executive Summary

Drug Review Profile: Labeling, unique fee structure among many challenges that Inflectra sponsor Celltrion and FDA had to navigate in nascent regulatory pathway.

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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.

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.

With Inflectra, FDA Showed Flexibility On Biosimilar Pediatric Study Plans

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.

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