Bio-Thera Solutions Ltd.: BAT1706

BAT1706 and EU-Avastin did not meet the acceptance criteria, which may suggest the presence of interference that may impact the ability to accurately measure the BAT1706 and EU-Avastin concentrations.

Therefore, the PK data from Study BAT1706-001-CR could not be used to support a demonstration of biosimilarity or establish the PK component of the scientific bridge to support the relevance of data generated using EU-Avastin as the comparator product in study BAT1706-003-CR.

BAT1706 has no clinically meaningful differences from US-Avastin in terms of safety, purity, and potency.

(LLOQ) and high quality control (HQC) to establish the selectivity of the bioanalytical method for BAT1706 and EU-Avastin.

FDA must assess the ability of that facility to conduct the listed manufacturing operations in compliance with CGMP.

Complete Response Letter while the travel restrictions remain in effect.

However, even if these deficiencies are addressed, the application cannot be approved until the required FDA inspection is conducted and any findings are assessed regarding your application.

Please see the FDA's "Resiliency Roadmap for FDA Inspectional Oversight" for more information on FDA's plan to resume inspections (https:/Awww.fda.gov/media/148197/download).

Update Section 3.2.P.3.3 of the BLA with information on BAT1706 DP shipping to the US warehouse/distribution sites, including information for the shipping routes and temperature, shipper (e.g., details of the active shipper), minimum and maximum loads, temperature monitoring during routine shipments, and the validated shipping duration.

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