GC Biopharma, a global biopharmaceutical company dedicated to specialty plasma-derived therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of the Biologics License Application (BLA) for its GC5107B (Immune Globulin Intravenous (Human) for patients with primary humoral immunodeficiency (PI).

The Prescription Drug User Fee Act (PDUFA) target action date is January 13, 2024. If approved, GC Biopharma would be able to provide more treatment options for patients with PI in the U.S.

GC Biopharma aims to enter the U.S. market in the second half of 2024 if GC5107B is approved by the FDA as anticipated.

While the U.S. immunoglobulin market size is estimated at about US$ 10.4 billion in 2022 (as per MRB 2022), there have been sporadic shortages as there are only a small number of immunoglobulin manufacturers considering the need for a massive investment in facility and sophisticated production know-hows.

GC5107B is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes three steps to reduce the risk of virus transmission. The steps are "Fractionation I+III, solvent/detergent (S/D) treatment, and Nanofiltration."