Green Cross 'Aliglo' Breaks Through Major PBM Gateway to Enter US Market

GC Green Cross announced on the 2nd that it signed a contract on the 1st (local time) with a major prescription benefit manager (PBM) in the United States to list the immunoglobulin blood product Aliglo in the prescription formulary.

GC Green Cross's immunoglobulin blood product 'Aliglo'
Photo by GC Green Cross

Aliglo received approval from the U.S. Food and Drug Administration (FDA) in December last year. It is a 10% intravenous immunoglobulin preparation used to treat primary immunodeficiency, also known as congenital immune deficiency. Since obtaining product approval, Green Cross has been preparing for commercialization centered on its U.S. subsidiary, GC Biopharma USA, by negotiating PBM contracts and securing specialty pharmacies.

PBMs are considered the first gateway to entering the U.S. market. Pharmaceuticals sold in the U.S. are practically difficult to sell if they are not listed in the prescription formulary, a drug list managed by PBMs on behalf of public and private insurance. If Aliglo is not listed in the formulary of the insurance company the patient is enrolled in, the patient must bear the full cost of the drug to use Aliglo. Conversely, if Aliglo is listed in the formulary, the patient pays only the copayment amount with insurance benefits.

Therefore, success in the U.S. market depends on being listed in the formularies of various PBMs, led by the so-called "Big Three PBMs"?CVS Caremark, Express Scripts, and OptumRx?which currently dominate about 80% of the PBM market. Aliglo has opened the first path by successfully being listed in a major PBM formulary. Additionally, it is sequentially signing contracts with well-known specialty pharmacies, the core distribution channels, aiming for a launch within this month.

Green Cross also aims to secure about 80% of U.S. private insurance subscribers through vertically integrated channel contracts encompassing insurers, PBMs, specialty pharmacies, and distributors, by pursuing contracts with 3 to 5 additional PBMs.

Currently, Aliglo received shipment approval from the FDA on the 21st of last month, and the first shipment is expected to begin as early as next week. After export and distribution processes within the U.S., actual prescriptions are anticipated to be possible from mid-month.

A GC Green Cross official said, “This PBM contract is a significant advancement for both the company and patients in the U.S. who need Aliglo,” adding, “We will continue efforts to improve patient access to innovative treatments through partnerships with stakeholders such as PBMs, specialty pharmacies, and distributors in the U.S.”