FDA staff who participated in the agency's review of Celltrion's infliximab-dyyb, a biosimilar to Janssen's Remicade.
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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.
Drug Review Profile: Labeling, unique fee structure among many challenges that Inflectra sponsor Celltrion and FDA had to navigate in nascent regulatory pathway.
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.