South Korea’s Green Cross said Friday that it expects to launch its immunodeficiency drug in the US market next year, as it will be submitting the additional data required for approval to the US drug regulators within the next few months.

The company said it has been working with the US Food and Drug Administration to prepare additional production-related data on its drug IVIG-SN, human normal immunoglobulin G for intravenous administration, and that such procedures are now near-complete.

“We are close to filing the additional production-related data to the FDA, the timing of which could be within this year or early next year. What is certain is that the drug will be approved and launched next year,” a Green Cross spokesperson said.

The development comes around a year since the US drug regulator rejected Green Cross’ biologics license application for IVIG-SN, asking the company to provide supplementary information on the drug’s manufacturing procedures.

Analysts here expect the drug candidate will receive final marketing authorization without issue once the additional data is filed, as the FDA had not problematized the drug’s efficacy or safety in its request.

Exclusively developed by Green Cross, IVIG-SN is a plasma-derived protein drug that treats primary immunodeficiency disorders which weaken or rids 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.

If approved in the US, it would allow Green Cross to significantly expand its footprint in North America as well as the global market for IVIG-SN and injectable plasma-derivative drugs.

The US is currently the largest and the most lucrative market for IVIG-SN. The country generates around 7 trillion won ($6.1 billion) in annual sales, accounting for around 40 percent of the drug’s global market, according to HMC Investment Securities.

As part of ongoing efforts to expand its presence in North America, Green Cross has invested 180 billion won toward building a new biologics plant for producing plasma-derivative protein therapies in Montreal, Canada.

The plant was officially completed earlier this month. Looking ahead, it is slated to manufacture plasma-derived drugs like intravenous immunoglobulin and albumin. However, commercial production is expected to start in 2020, after the facilities obtain regulatory clearance.

As it will take some time before the plant is commercially operational, Green Cross said it plans to initially produce IVIG-SN to be sold US, at its existing FDA-compliant facilities in Ochang of North Chungcheong Province in Korea.

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