Tanvex BioPharma USA, Inc.: TX05

December 29, 2025, which constituted a complete response to our January 3, 2025, action letter.

), listed in this application, the FDA conveyed deficiencies to the representative of the facility.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application.

Assessment Data Review Report identified several issues regarding data omission in the analysis of G-CSF receptor binding by SPR © assay) as indicated in the March 15, 2021 Information Request (IR).

September 24, 2019, issues were raised regarding data omission for the competitive binding ELISA assay.

In the response to the March 15, 2021 IR, you provided a list of all the runs and samples that were excluded from the analysis.

November 20, 2020. We reserve comment on the proposed container label and carton labeling until the application is otherwise adequate.

Please refer to your biologics license application (BLA) dated September 28, 2018, received September 28, 2018, and your amendments, submitted under section 351 (k) of the Public Health Service Act for TX01.

1. During a recent inspection of Tanvex, Inc. manufacturing facility (FEI: 3013021112) for this BLA, our field investigators conveyed deficiencies to the representatives of the facility.

Satisfactory resolution of these deficiencies is required before this application may be approved.

These issues may negatively impact the reliability of the data provided to demonstrate that TX01 is highly similar to U.S.- licensed Neupogen.

The retrospective review is necessary to support a determination that TX01 is highly similar to U.S.-licensed Neupogen.

The Agency recommends that prior to initiating the internal or external third-party audit, the scope of the audit should be clearly pre-defined to address the items below.

2016 and 2018 comparative analytical studies.

You attributed these differences to variability in experimental conditions between the 2016 and 2018 studies.

Address whether the minor peaks reported in Table 4 are also found in U.S.-licensed Neupogen in similar levels and provide comparative data showing the abundance of these peaks in TX01 and U.S.- licensed Neupogen.

5. Two comparative analytical studies were conducted, one in 2016 and a second study in 2018. During the inspection of the Tanvex Inc. facility (FEI: 3013021112)

The summary indicated that several of the methods used in the 2016 study were not qualified, and/or formal system suitability criteria were not established.

Provide evidence that the non-qualified methods and those run without system suitability criteria as indicated in the inspection document "Summary of the History of Changes to the Methods and Reference Standards used for Analytical Similarity Assessment" were suitable for their intended use during the 2016 comparative analytical study.

However, based on the information in reports# TR-2015-010-00 and SAN-VAL-0098 provided in the 351(k) BLA, the method was not validated for quantitation of basic species.

We reserve comment on the draft carton and container labeling until the application is otherwise adequate.

In addition, provide a risk assessment and supporting data to address the potential leachables derived from the drug substance manufacturing process and their potential impact on product quality and patient safety.

These acceptance criteria appear to be based on the drug product specifications using the previous potency assay with high method variability.

Your data, show that the potency of TX01 at &megimL concentration is about 0% in the LV.

For this purpose, first-cycle actions include approvals, complete responses, and withdrawals after filing.