FDA approves first-ever Korean blood product to enter U.S. market

GC Biopharma headquarters in Gyeonggi [GC BIOPHARMA]

GC Biopharma’s blood product won approval from the U.S. Food and Drug Administration (FDA), the pharmaceutical company said Monday.

GC Biopharma’s Alyglo is the eighth FDA-approved drug developed by a Korean company and the first domestically developed blood product to enter the U.S. market.

GC Biopharma plans to market Alyglo in the United States through its American subsidiary, GC Biopharma USA, by the latter half of next year.

Alyglo, an intravenous immune globulin, is a treatment for patients aged 17 and older with primary humoral immunodeficiency, also known as PI, which encompasses a number of different conditions that impact immunity.

The U.S. immune globulin market size was valued at a total of $10.4 billion in 2022, according to the Marketing Research Bureau.
The FDA approved Alyglo on Friday, about a month earlier than it was expected to.

The FDA has rejected GC Biopharma twice since 2015, when the company initially submitted a blood product with a lower level of immune globulin than Alyglo's.

The company conducted Phase 3 clinical trials with Alyglo in the United States and Canada in 2020. It applied again for a biological license in July of this year after the FDA conducted a pre-license inspection of North Chungcheong manufacturing facility.

Alyglo is the second domestically developed drug to win FDA approval this year, following Celltrion’s Zymfentra, which was greenlit for the U.S. market in October. Hanmi Pharmaceutical’s Rolontis received FDA approval in 2022.

Samsung Securities Senior Analyst Seo Keun-hee expects Alyglo to generate 15.6 billion won ($12 million) next year, according to a report published Monday. The figure is estimated to reach 233.6 billion by 2028.

“The initial cost may temporarily increase due to expenses spent to purchase blood in the United States and marketing. But since the immune globulin price in the U.S. is about five times higher than in Korea, the cost burden is expected to be quickly alleviated as Alyglo’s sale grows,” said Seo.

BY SHIN HA-NEE [shin.hanee@joongang.co.kr]