Generic HIV prevention injection moves closer to 120 countries after FDA approval

NAIROBI, Kenya, Nov 2– Access to a twice-yearly HIV prevention injection is moving closer to millions of people in low- and middle-income countries after Dr. Reddy’s Laboratories secured tentative approval…

The regulatory milestone, secured just 16 months after approval of Gilead Sciences’ original product, could accelerate the availability of a more affordable long-acting HIV prevention option in 120 low- and middle-income countries, with initial supplies expected to reach countries by the end of 2026.

The generic version is expected to be priced in line with oral pre-exposure prophylaxis (PrEP), potentially making the twice-yearly injection more accessible to people at risk of HIV who may find taking daily preventive pills challenging.

The development follows a pricing agreement announced in September 2025 between Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI) and Dr. Reddy’s, combining an early pricing commitment with financial, technical and regulatory support to accelerate the generic’s development and market entry.

Source: Capital FM