Tanvex BioPharma USA, Inc – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Tanvex BioPharma USA, Inc. for its Biologics License Application (BLA) for TX01, submitted under section 351(k) of the Public Health Service Act for biosimilar approval. The agency concluded that the application cannot be approved in its current form due to significant deficiencies.

Key issues included unsatisfactory conditions observed during inspections of Tanvex BioPharma's manufacturing facility and another unnamed facility. The FDA requires satisfactory resolution and verification of these objectionable conditions.

Furthermore, the agency identified critical problems with the comparative analytical assessment, specifically citing data omissions and inadequate justifications for excluded data in G-CSF receptor binding analyses (SPR and ELISA assays). These issues raised concerns about the reliability and quality of the submitted data, leading the FDA to determine there was insufficient information to establish that TX01 is highly similar to the U.S.-licensed reference product, Neupogen.

To address these deficiencies, Tanvex must resolve the facility inspection issues and provide reliable comparative analytical data using assays demonstrated to be fit for purpose, including commercial and clinical study lots of TX01. The company is also required to resubmit its proposed proprietary name, NYPOZI, and provide a comprehensive safety update detailing any significant changes and comparing adverse event frequencies. Comments on labeling are reserved pending resolution of these primary issues.