Research Paper 232, 9 April 2026
Addressing Barriers to Accessing Monoclonal Antibodies (mAbs) in Developing Countries: Challenges and Potential Solutions
By Nirmalya Syam
Monoclonal antibodies (mAbs) have revolutionized treatment in oncology, autoimmune disorders, and infectious diseases due to their high specificity and efficacy. However, access to mAbs in developing countries remains severely limited due to high costs, market concentration in high-income regions, regulatory hurdles, and intellectual property barriers. Despite the potential of biosimilars to enhance affordability, their availability remains restricted due to expensive development processes, patent thickets, and complex regulatory requirements. The dominance of multinational pharmaceutical companies in the market further restricts competition, delaying biosimilar approvals and preventing price reductions. Additionally, regulatory agencies in developing countries often lack the resources to expedite biosimilar approvals, further exacerbating delays in access.
Policy interventions such as improved regulatory harmonization, stricter patent examination guidelines, and expanded public investment in mAb production are necessary to address these barriers. The adoption of the revised 2022 WHO Similar Biotherapeutic Products (SBP) Guidelines could streamline biosimilar approval by reducing unnecessary comparative clinical trials. Moreover, technology transfer initiatives and market-shaping incentives, including compulsory licensing, could help lower costs and accelerate the availability of mAbs in underserved regions.
By implementing these strategies, developing countries can bridge the access gap, ensuring that lifesaving mAb therapies reach the patients who need them most. A coordinated global effort involving policymakers, regulators, and industry stakeholders is essential to establishing a sustainable and equitable mAb supply chain.