Long-acting HIV medicines have the potential to transform both treatment and prevention, reducing pill burden, improving adherence, and better reflecting what people living with or at risk of HIV consistently say they want. Yet despite their promise, access to these innovations remains limited, particularly in low- and middle-income countries (LMICs).

A paper published in February 2026, Accelerating Generic Long-Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access, takes a close look at why that gap persists, and what can be done to close it. This report summarises key discussion points, findings, and outcomes from an international workshop on generic long-acting (LA) antiretrovirals (ARVs) co-organised by the Long-Acting/Extended-Release Antiretroviral Resource Program (LEAP) and the Centre of Excellence for Long-acting Therapeutics (CELT). The workshop brought together regulators, scientists, generic manufacturers, civil society and global health organisations to outline practical pathways to accelerate access to affordable, generic LA ARVs.

Dr Charles Flexner, Professor of Medicine at Johns Hopkins University and Principal Investigator of LEAP programme

To accompany the publication, MPP interviewed Dr Charles Flexner, Professor of Medicine at Johns Hopkins University and Principal Investigator of LEAP programme, co-author of the paper and co-organizer of the workshop.

A strong preference, limited access

Long-acting formulations are widely recognised as a major advance in HIV care. Across regions, surveys consistently show that many people prefer long-acting options over daily oral treatment or prevention. Yet uptake remains low, even in high-income countries, and access in lower-income settings remains largely out of reach.

“There is a significant gap between what the public wants and what we, as healthcare providers and institutions, can actually deliver,” says Dr Flexner. “Despite the availability of long-acting injectables for several years now, they still represent only a very small share of the treatment market.”

For global access, the availability of affordable generics is essential.

“Without low-cost generic versions of these incredible products, they will never reach the people who need them most in low- and middle-income countries,” Dr Flexner explains. “Even if originator companies were willing to provide them at cost, they would still be far more expensive than the daily oral therapies most of the world relies on today.”

Why long-acting generics face unique barriers

Generic medicines are the backbone of global HIV treatment, but long-acting formulations pose challenges that existing regulatory systems were never designed to address.

To approve a generic medicine, regulators require proof that it behaves in the body in the same way as the originator product. For long-acting injectables, this means tracking drug levels over long periods of time, sometimes many months.

“With the traditional economic model, the current regulations make it nearly impossible for generic manufacturers to bring long-acting formulations to market,” says Dr Flexner. “In some cases, the studies required to demonstrate bioequivalence would last more than a year.”

Such prolonged studies are costly and complex, and far outside the economic model of most generic manufacturers.

“The generic industry operates on very narrow margins,” he adds. “They’ve never before been expected to generate this kind of long-term clinical data just to get a product approved.”

A roadmap for accelerating access

Parag Nimbolkar, Business Development Senior Manager, In-licensing at Medicines Patent Pool, during the workshop, February 2026

The paper Accelerating Generic Long-Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access grew out of a multi-stakeholder workshop that brought together regulators, academic researchers, originator and generic manufacturers, civil society organisations and global health institutions, including MPP. The goal was to identify scientifically sound and practical ways to shorten development timelines for generic long-acting medicines.

Two major approaches emerged.

Using smarter science to shorten timelines

The first is the use of advanced statistical modelling, including Bayesian forecasting, to predict long-term bioequivalence using shorter studies.

“If the regulation says you need twelve months of data, but you have four or six months of data and the two products look equivalent, the key question becomes: what’s the likelihood they will not be equivalent at twelve months?” Dr Flexner explains. “That’s exactly what Bayesian forecasting allows you to assess.”

Importantly, regulators are increasingly open to these methods.

“At least in the United States, the FDA has been very receptive to the idea of using Bayesian forecasting in regulatory submissions,” he says. “That makes this a very promising pathway.”

Biowaivers for certain formulations

The second, and potentially most impactful, option is the expanded use of biowaivers. For drugs formulated as simple solutions rather than complex long-acting nanoparticles, regulators may waive the requirement for human bioequivalence studies altogether, provided the generic formulation is identical to the originator.

“In those cases, the scientific assumption is that if the concentration of the drug and all other components is the same, and it’s delivered in the same way, the pharmacokinetic behaviour will be identical,” says Dr Flexner. “And that assumption is supported by real-world data.”

This pathway could be particularly relevant for medicines such as lenacapavir.

“A generic version of lenacapavir, because it’s a solution, could potentially be approved without a single study in human subjects,” he explains. “That’s very different from cabotegravir, where much longer bioequivalence studies are required.” Cabotegravir is formulated as a complex nanosuspension rather than a simple solution, which means generic developers must run full pharmacokinetic studies to demonstrate bioequivalence. The studies that can last more than a year need to include a large number of participants due to the high interindividual variability. For this reason, the duration of generic development of cabotegravir, is longer than for lenacapavir. There are however encouraging signs of regulatory movement on this front: in October 2025, the US FDA issued revised draft guidance that would allow generic manufacturers developing both long-acting cabotegravir and the cabotegravir/rilpivirine combination to cross-reference bioequivalence data between the two products, potentially reducing the number of clinical studies required when developing generic versions for both indications, PrEP and treatment, which is relevant for ViiV-MPP license that envisions broad access for both indications.

MPP’s contribution: evidence, policy and transparency

The paper highlights public-health-oriented voluntary licensing (MPP’s core mechanism) as one of the most effective ways to navigate the complex intellectual property landscape surrounding long-acting therapeutics and to enable timely generic entry in low- and middle-income countries. MPP’s role in this workshop reflects its broader work at the intersection of intellectual property, public health policy and access, working with governments, manufacturers and global health partners to expand access to new HIV therapeutics.

MPP also coordinates LAPaL with support from Unitaid and NIH funding through LEAP. LAPaL is curated in partnership with the University of Liverpool’s CELT. It is a resource Dr Flexner describes as long overdue.

“In the history of HIV drug development, there has never been a centralised database tracking where long-acting products are in development, where they’re approved, and what the intellectual property situation looks like,” he says. “LAPaL provides that for the first time.”

Beyond regulatory status, LAPaL tracks which populations have been included in clinical trials, such as children, adolescents and pregnant women, as well as licensing and patent information.

“That kind of transparency is extremely valuable,” Dr Flexner adds. “It helps researchers, funders, governments, manufacturers and advocates all work from the same evidence base.”

Measuring success: from approval to real-world use

Looking ahead, Dr Flexner says progress must be measured not only in regulatory milestones, but in real-world impact.

“In three to five years, I would want to see more generic long-acting products approved, and actually being rolled out and used by the populations who stand to benefit from them the most,” he says.

He also points to the importance of extending long-acting innovation beyond HIV.

“We already have a long-acting formulation for tuberculosis in clinical development (long-acting bedaquiline), which is very exciting,” he notes. “And we hope to see similar progress for hepatitis B and hepatitis C in the near future.”

The roadmap set out in the paper makes clear that accelerating access to long-acting HIV medicines is not a question of scientific possibility, but of regulatory adaptation, collaboration and political will. With coordinated action, the promise of long-acting technologies can move closer to reality, for everyone, everywhere.

Read the full paper:
Accelerating Generic Long-Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access, Arshad U, Gaayeb L. et al.,
Clinical Pharmacology & Therapeutics, February 2026.