# Global Fund Prepares for Major Expansion in Access to Lenacapavir as Generic Supply Approaches

**GENEVA** – The Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) is working with countries, partners and communities to prepare for a significant expansion in access to lenacapavir for HIV prevention, as additional supply of generic versions of the product are expected to become available in the coming months.

Lenacapavir – a twice-yearly injectable option for HIV prevention – has the potential to transform the HIV response, particularly for people who face barriers to using existing prevention options. The priority now is to translate that potential into access at scale, as rapidly as possible.

Demand from countries has been strong, reflecting both the significant interest in lenacapavir and the urgent need for additional HIV prevention options. Meeting this unprecedented level of demand will require a combination of Gilead Sciences supply and quality-assured generic products. Accelerating regulatory approvals, procurement pathways and readiness for generic products will be critical to ensuring countries can access the additional supply needed to meet demand. To help accelerate this effort, the Global Fund launched a [global call for Expressions of Interest in April 2026](/en/sourcing-management/updates/2026-04-07-opportunity-evaluation-finished-pharmaceutical-products-lenacapavir-pre-exposure-prophylaxis/), inviting manufacturers to submit their lenacapavir for pre-exposure prophylaxis (PrEP) products for review by its Expert Review Panel mechanism. This expedited approval pathway will enable eligible generic products to be procured through the Global Fund’s Pooled Procurement Mechanism, wambo.org, and other channels as they become available.

“The extraordinary demand we are seeing for lenacapavir is a powerful signal of the opportunity ahead,” **said Peter Sands, Executive Director of the Global Fund**. “Our focus is on turning that demand into access at scale – working with countries and partners to expand supply, accelerate the introduction of quality-assured generics and drive down costs. We have a clear path forward, and we are determined to move as quickly as possible to ensure this breakthrough innovation reaches the people and communities who can benefit from it.”

The expected introduction of generic lenacapavir represents a critical next step. By expanding and diversifying the supplier base, generic products will significantly contribute to the ambitious scaled rollout of lenacapavir for PrEP and help countries to broaden access and drive uptake through more sustainable and resilient supply chains. Initial generic supply is anticipated in late 2026, with broader availability expected during 2027. Critical to access is country-level regulatory approval and registration of all sources to ensure that available volumes address all demand.

The Global Fund and the United States remain focused on the ambition of reaching 3 million people with lenacapavir by the end of 2028. Plans for 2027 envisage a significant acceleration in access as generic supply becomes available, bringing the partnership substantially closer to achieving that ambition.

“Strong country demand is exactly why expanding the supplier base is so important,” **said Hui Yang, Head of Supply Operations at the Global Fund**. “We are working with countries, partners and manufacturers to manage available supply in the near term while preparing for a significant expansion as generic products become available. A more diverse supplier base will give us greater access, greater resilience and the ability to reach many more people. Our priority is to make that expansion as quickly and smoothly as possible.”

The acceleration of generic lenacapavir has been made possible through close collaboration across the global health partnership. This includes Gilead Sciences’ early voluntary licensing agreements with generic manufacturers, alongside the work of the Global Fund with the Children’s Investment Fund Foundation, the Gates Foundation, Unitaid, the US Department of State Bureau of Global Health Security and Diplomacy (GHSD) and other partners to accelerate the development and availability of quality-assured generic products and help create the conditions for rapid and equitable scale-up as additional supply becomes available.

The experience with lenacapavir reinforces a broader lesson for global health: Scientific innovation only delivers its full impact when the systems, markets and partnerships are in place to make it available rapidly, affordably and at sufficient scale.

The Global Fund remains committed to working with governments, communities, manufacturers and partners to accelerate access to lenacapavir and other innovations, expand options in HIV prevention and help drive faster progress toward ending AIDS as a public health threat.