Overcoming barriers for expanding market access to follow-on biologics in lower-middle-income countries

Introduction Biologic therapies are highly effective for cancers, autoimmune and inflammatory conditions, diabetes, and other chronic diseases, yet remain largely out of reach in low- and lower-middle-income countries despite the rising non-communicable disease burden in these countries. Only about 1 billion of the world’s 8 billion people can access biologics, concentrated in upper-middle- and high-income countries. Focusing on lower-middle-income countries (L-MICs), we assess barriers to originator and follow-on biologics (FOBs) and the opportunities to overcome them. Profiles of six geographically dispersed L-MICs serve as exemplars of the current capabilities and challenges of providing biological therapy in these countries.Areas Covered Regulatory, manufacturing and supply-chain, infrastructure, financing, and clinical constraints in L-MICs were identified as barriers to accessibility to biologics and FOBs. Actionable opportunities to overcome them include regulatory harmonization and reliance, technology transfer and local production, pooled procurement, income-indexed differential pricing, prescriber education, and clinician and patient trust campaigns. The cost-efficiencies that lower-cost FOBs can generate at equivalent clinical benefit could be reinvested to expand access on a budget-neutral basis. The profiles of the six selected L-MICs demonstrated heterogeneity with regards to population size, disease burden, and current capabilities and challenges to expand access to FOBs.Conclusions The access gap is now less about molecules than about the architecture around them. Aligning the fair-profit motive with the access imperative can make expansion a growth strategy rather than charity, with regulatory reliance and differential pricing as near-term unlocks and the coupling of cost-efficiency to expanded access as the organizing logic. Framing recommendations across micro, meso, and macro levels, we propose a shared, adaptable blueprint that lets each country copy and adapt to open new markets, close treatment gaps, and contribute meaningfully to global health equity.