In February 2026, the article «Accelerating the Introduction of Long-Acting Generic Antiretroviral Drugs for HIV Treatment: Workshop Results and an Accessibility Roadmap» was published. It summarizes the results of an international workshop organized by the LEAP program and the Center of Excellence for Long-Acting Therapeutics (CELT). Dr. Charles Flexner, a professor at Johns Hopkins University and principal investigator of the LEAP program, highlighted the key problem in an interview with the Medicines Patent Pool: «There is a significant gap between what patients want and what is actually available. Despite the preference for long-acting drugs, their market share remains very small.»
The main difficulty lies in the requirements for proving the bioequivalence of generic drugs. For long-acting injectable forms, this requires lengthy studies (up to a year or more), which makes development economically unviable for manufacturers.
«Without inexpensive generics, these innovative drugs will never reach those who need them most,» Flexner noted. «Even if the manufacturing companies were willing to provide them at cost, they would still be much more expensive than the daily oral drugs that most of the world relies on today.»
Workshop participants proposed two main ways to speed up the process: using modern statistical methods to shorten clinical-study timelines, and easing regulatory requirements for simple solutions (for example, lenacapavir). «Because lenacapavir is a solution, its generic equivalent could potentially be approved without conducting any human studies,» Flexner explains. «This is very different from cabotegravir, which requires much longer bioequivalence studies.» Cabotegravir is produced as a complex nanosuspension, which means generic developers must conduct full pharmacokinetic studies to demonstrate bioequivalence.
A resource called LAPaL has also been launched — the first centralized database on the development status, approval, patents, and studies of long-acting ARV drugs. Dr. Flexner emphasized that success should be measured not only by the number of approved drugs but by their real-world adoption among the most vulnerable populations.