Unitaid, IAVI, Medicines Patent Pool, and Wellcome publish novel approaches to enable equitable access to monoclonal antibodies in low- and middle-income countries

Unitaid, IAVI, the Medicines Patent Pool and Wellcome proudly announced the publication of “Novel Approaches to Enable Equitable Access to Monoclonal Antibodies in Low- and Middle-Income Countries” in PLoS Global Public Health. A collaborative effort across IAVI’s lead author Shelly Malhotra, vice president for global access and external affairs, and co-authors from partner organizations, the article draws on a multistakeholder consultation, to address critical barriers and proposes innovative strategies to enable equitable access to monoclonal antibodies (mAbs) in low- and middle-income countries.

Monoclonal antibodies – lab-engineered antibodies that mimic human antibodies in defending against disease – are revolutionizing the management of various non-communicable and autoimmune diseases in high-income countries. Some mAbs have also been approved for infectious diseases, and many others are currently in development. However, due to systemic challenges, access to mAbs in low- and middle-income countries remains very limited.

This publication describes the challenges inhibiting the accessibility of mAbs in low- and middle-income countries, which include prohibitive costs and ill-adapted formulations, insufficient investment in development for mAbs that target infectious diseases, limited production base, complex intellectual property and regulatory environments and inadequate commercial incentives in low- and middle-income country markets. It outlines possible approaches to overcome these challenges across the value chain, including development and manufacturing, licensing and technology transfer, regulatory pathways, demand creation, and approaches specific to diseases facing different market challenges.

The article provides key recommendations for making these powerful tools more accessible and affordable in regions where they could address unmet needs in the global health response and accelerate progress toward global targets. IAVI and partners remains committed to working with global health agencies, funders, the private sector, and affected communities to enable equitable access to mAbs for infectious diseases in low- and middle-income countries.