Novel approaches to enable equitable access to monoclonal antibodies in low- and middle-income countries

• DOI: 10.1371/journal.pgph.0003418
• Publication Date: 2024-07-01T17:31:20Z
• Authors: Shelly Malhotra; Anne-Isabelle Cam...; Dzintars Gotham; Esteban Burrone; Peter J. Gardner; Colleen Loynachan; Sébastien Morin; Cherise P. Scott; Carmen Pérez-Casas
• Keywords: Biosimilar; Market access; Investment

Monoclonal antibodies (mAbs) are revolutionizing management of non-communicable diseases in high-income countries and increasingly being advanced for a range infectious (IDs). However, access to existing mAbs is limited low- middle-income (LMICs), investment developing fit-for-purpose IDs that disproportionately affect LMICs has been limited. Underlying these barriers systemic challenges, including lack commercial incentives target LMIC markets complexity manufacturing regulatory processes. Novel strategies needed overcome mAbs. We outline key areas where new approaches could address barriers, based on multistakeholder consultation March 2023. Three disease-market archetypes identified guide thinking about business models tailored different contexts. New incentivize development ID ensure optimized with product profile cost goods enable use diverse settings. Lessons can be applied from voluntary licensing partnerships have shown success catalysing affordable supply diseases. Technology transfer will expand research capacity sustainable diversified supply. Improved market intelligence, demand aggregation mechanisms, portfolio-based used de-risk establish ecosystem robust technology may reduce data requirements timelines biosimilar approvals. Trailblazer products, coordinated “end-to-end” support funders, demonstrate proof concept pathways accessible across broader LMICs. Research funders; local, regional, global health agencies; and, private sector partners should commit implementing innovative end-to-end equitable