Benefits and perils of generic drugs for hematologic neoplasms and their use in low- and middle-income countries: a narrative review

The global landscape of hematology stands at a critical juncture, characterized by the stress between therapeutic innovation and equitable access. Generic drugs, biologics, and biosimilars have emerged as the single most potent apparatus for bridging this divide, especially in low- and middle-income countries. Access to treatment for life-threatening hematologic illnesses has vastly improved with the availability of generic drugs, however, significant challenges remain with respect to their quality, efficacy, and safety, and these remain largely unaddressed. This comprehensive review offers an analysis of the dual nature of generic hematology medications, namely their capacity to democratize survival through cost reductions, balanced against the authentic perils of variable quality, regulatory issues, and therapeutic inconsistency. This report highlights that although quality-assured generics offer therapeutic equivalence to innovator products, the prevalence of substandard formulations in resource-limited settings constitutes a silent public health crisis. We integrated evidence regarding the methodologies used to show bioequivalence, supply chain vulnerabilities, and health system economics to propose a robust framework for the safe integration of generic medicines in health care delivery. The analysis concludes that realizing the promise of generic hematology drugs requires a paradigm shift from passive procurement to active quality assurance, underpinned by strengthened regulatory frameworks, international patent flexibilities, and comprehensive pharmacovigilance.