GC Biopharma secures PBM deal to launch blood product Alyglo in US

GC Biopharma said on Monday that it has signed an agreement with a U.S. pharmacy benefit manager (PBM) to include Alyglo in its formulary.

Alyglo, an  immunoglobulin blood product approved by the U.S. Food and Drug Administration (FDA) December last year, is a 10 percent intravenous immunoglobulin for the treatment of primary humoral immunodeficiency (PI), also known as congenital immunodeficiency. 

Since the approval, the company has been preparing for commercialization through its U.S. subsidiary, GC Biopharma USA, negotiating PBM contracts and securing specialty pharmacies.

PBMs are third-party administrators contracted by health plans, large employers, unions, and government entities to manage private insurance prescription drugs, and inclusion in a PBM formulary means inclusion in the U.S. health insurance benefit system. Listing on multiple formularies is crucial to improving access to medicines, said a spokesperson for GC Biopharma. 

The company also said it signed agreements with specialty pharmacies, which are “key distribution channels,” and is accelerating its launch efforts this month.

GC Biopharma said it aims to reach approximately 80 percent of U.S. private payers through vertically integrated channel agreements with insurers, PBMs, specialty pharmacies, and distributors, with three to five additional PBMs in the pipeline.

GC Biopharma also received a notification of lot release from the FDA on June 21. The company is currently making final preparations for the first shipment from the Ochang Energy Plant expected as early as next week. 

The batches will be delivered to warehouses and distributors in the U.S. and then to specialty pharmacies, becoming available for prescription by the middle of this month.

The U.S. immunoglobulin market, valued at approximately 16 trillion won ($11.6 billion),  has grown at a compound annual growth rate of 10.9 percent over the past decade (2013-2023), according to GC Biopharma. The company's  strategy is to generate $50 million in revenue this year and sustain annual growth of more than 50 percent to rapidly expand  its market share.

"This PBM agreement is a great step forward for both the company and the patients in the U.S. who need Alyglo," said a GC Biopharma representative. "We look forward to continuing our efforts to improve patient access to innovative therapies through partnerships with stakeholders including PBMs, specialty pharmacies, and distributors in the U.S."