FDA CRL - Samsung Bioepis Co., Ltd

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Samsung Bioepis Co., Ltd. concerning their Biologics License Application (BLA 761066) for SB4, submitted on May 25, 2017, under section 351(k) of the Public Health Service Act. The FDA was unable to approve the application in its current form due to several product quality deficiencies.

Key issues included the primary and working reference standards not being appropriately qualified for biological activity and protein concentration, lacking assurance for commercial material consistency. The cell culture process control strategy was deemed inadequate, specifically regarding the representativeness of studies and the clonality of the cell bank. Furthermore, the proposed drug product filling control strategy did not sufficiently guarantee that pre-filled syringes met the specified label claims, citing discrepancies in protein concentration, inappropriate extractable volume limits, and insufficient detail on real-time monitoring. Lastly, the provided data for commercial drug product shipping validation was considered inadequate to assure product quality during distribution.

To address these concerns, Samsung Bioepis must generate appropriately qualified reference materials linked to clinical data, establish robust cell culture controls, revise drug product specifications and filling control strategies with justified limits and real-time monitoring details, and provide comprehensive shipping validation data from representative studies.