GC Biopharma ships first U.S. supply of blood product Alyglo

GC Biopharma said on the 8th that it had completed shipment of the initial supply of its blood product ALYGLO, which received U.S. Food and Drug Administration (FDA) approval late last year. The shipment will pass through U.S. warehouses and distributors before reaching specialty pharmacies, with prescriptions expected to become available from mid-month.

Approved by the FDA in December last year, ALYGLO is a 10% intravenous immunoglobulin product used to treat primary humoral immunodeficiency, also known as primary immunodeficiency.

Since receiving approval, the company has been preparing for commercialization, including signing contracts with pharmacy benefit managers (PBMs) to secure formulary listings and building a network of specialty pharmacies, led by its U.S. subsidiary, GC Biopharma USA, Inc.

On the 1st, GC Biopharma signed a contract with a major U.S. pharmacy benefit manager (PBM) to secure a formulary listing for ALYGLO. It has also finalized contracts with leading specialty pharmacies and distributors targeted as key distribution channels.

The company plans to expand its U.S. market channels by securing additional contracts across vertically integrated channels, including PBMs, specialty pharmacies and distributors.

The U.S. immunoglobulin market is the world’s largest, valued at about 16 trillion won ($11.6 billion)[1], and grew at an annual average rate of 10.9% over the past decade (2013–2023). GC Biopharma aims to generate $50 million in sales this year, then achieve annual growth of more than 50% to rapidly expand its market share.