GC Biopharma Corp’s eight-year endeavor has finally come to fruition as its blood product successfully enters the U.S. market. This achievement marks the first Korean blood product and the seventh new drug to receive approval from the U.S. Food and Drug Administration (FDA).
On Dec. 18, GC Biopharma Corp announced that its new blood product drug ALYGLO has been granted product approval by the FDA, just five months after submitting a BLA (Biologics License Application) in July.
ALYGLO is a 10% intravenous immunoglobulin product used for the treatment of immunodeficiency diseases. Blood products represent about 25% of GC Pharma’s total sales, making them a key product.
The U.S. product approval of ALYGLO represents a triumphant success after an eight-year challenge. In 2015, the company submitted a BLA for a 5% concentration product to the FDA but faced failures in entering the U.S. market in 2016 and 2017 due to supplementary requests from the FDA.
GC Biopharma Corp then reattempted entry into the U.S. market with a 10% concentration product, submitting a new application to the FDA in February 2021. However, in February the following year, the FDA did not grant approval, citing issues with the onsite inspection of the blood product factory in Ochang, North Chungcheon Province. The inspection had been conducted remotely due to the COVID-19 pandemic.
In response, GC Biopharma Corp conducted an onsite FDA inspection of the Ochang blood product factory in April last year. Following this, they resubmitted the BLA in July. Normally, an onsite inspection occurs after the BLA resubmission. The GC Pharma case is unusual, as the FDA made considerations due to the multiple attempts at product approval.
ALYGLO is the first Korean blood product to enter the U.S. market and the seventh domestically produced drug to receive FDA approval. This achievement follows Hanmi Pharmaceutical’s cancer adjuvant Rolontis in September last year, making it the second Korean drug to gain FDA approval in one year and three months.
GC Biopharma Corp is now poised to tap into the U.S. immunoglobulin market, which is valued at US$10.4 billion. GC Biopharma Corp plans to launch ALYGLO in the U.S. through its subsidiary, GC Biopharma USA, in the second half of next year. Significant sales are expected to begin the following year. The price of blood products is approximately 4 to 5 times higher in the U.S. than in Korea.