South Korean biopharma company GC Pharma said Friday that the US Food and Drug Administration has delayed the approval of the firm’s immunodeficiency drug IVIG-SN, demanding additional data related to the drug’s manufacturing procedures.

The company had initially expected the US FDA to grant final approval for IVIG-SN, short for human normal immunoglobulin G for intravenous administration, this month.

The company noted that the drug’s safety and efficacy are solid, as the product is already being sold in Korea and other countries, while stressing that refiling steps are common in the biopharma approval process.

“Additional data requirements are common in the drug marketing approval review process, particularly in the unique area of plasma-derivative medications. We plan to work closely with the FDA to resolve outstanding issues,” GC Pharma said in a statement.

Last year, the US drug regulator pushed back the drugmaker’s biologics license application for IVIG-SN, asking the company to provide supplementary information on the drug’s manufacturing procedures.

GC Pharma, formerly known as Green Cross, submitted the data in March this year in hopes of conclusive approval by September. But the FDA appears to remain unsatisfied with the firm’s manufacturing records.

Exclusively developed by GC Pharma, IVIG-SN is a plasma-derived protein drug that treats primary immunodeficiency disorders that weaken or rid the immune system’s ability to fight infectious diseases.

The drug, already being sold in more than 30 countries in Asia, South America and the Middle East, is one of the Korean drugmaker’s top-selling plasma-based biologic treatments.

With IVIG-SN, GC Pharma plans to target the US immunodeficiency disease treatment market, which makes up around half of the global market for this drug segment, estimated at around $10 billion.

By Sohn Ji-young (jys@heraldcorp.com)