GC Green Cross Immunoglobulin Product 'GC5107' Passes FDA Preliminary Review

GC Green Cross 'Ivy Globulin SN' (Provided by GC Green Cross)

[Asia Economy Reporter Chunhee Lee] GC Green Cross has passed the preliminary review by the U.S. Food and Drug Administration (FDA) for its immunoglobulin preparation 'GC5107'.

GC Green Cross announced on the 27th that the Biologics License Application (BLA) for GC5107 (domestic product name 'Ivyglobulin SN Injection 10%') has entered the full review process by the FDA.

The FDA's approval process typically involves a 60-day preliminary review after BLA submission. If the data is deemed appropriate, the FDA sets a target date for review completion and begins the full review. The FDA has set the target review completion date for GC5107 as February 25 of next year.

GC5107 is one of GC Green Cross's representative blood products used for various indications such as congenital immunodeficiency and immune thrombocytopenia. In February, GC Green Cross submitted the BLA to the FDA based on the results of the Phase 3 clinical trial in North America for GC5107.

GC Green Cross plans to launch the product locally in the United States in the second half of next year upon receiving final FDA approval as scheduled.

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