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Optimization of the Use of Generic Medications in Oncology: Improving Safety and Therapeutic Quality
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GómezAbreo, Diego
Alarcón Cano, Daniel F.
Ayala, Fernando
Belalcázar Carvajal, Nelson
Berrouet Mejía, Marie Claire
Beltrán, Oscar
Calderón-Ospina, Carlos Alberto
Castro-Salguero, Hugo
Marcela Escobar Cárdenas, Diana
Lema-Medina, Mauricio
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2025-08-09
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Resumen
Las enfermedades oncológicas constituyen una de las principales causas de mortalidad a nivel mundial, y el alto costo de las terapias representa una barrera crítica para los sistemas de salud. Los medicamentos genéricos han surgido como una alternativa para reducir costos y mejorar el acceso, pero su calidad, seguridad y eficacia siguen siendo objeto de debate, especialmente en oncología, donde se utilizan fármacos citotóxicos, formulaciones complejas y medicamentos con estrecho margen terapéutico. Este estudio reúne a un panel multidisciplinario de 19 expertos que, mediante una revisión narrativa de la literatura y un proceso Delphi en dos rondas, elaboraron recomendaciones de consenso. Los resultados destacan la necesidad de requisitos más estrictos de bioequivalencia y biodisponibilidad específicos para oncología, el fortalecimiento de la farmacovigilancia, la estandarización de protocolos de intercambiabilidad terapéutica, la participación activa de los médicos en decisiones de formularios, la armonización regulatoria regional y la ampliación de la investigación en marcadores farmacocinéticos oncológicos. En conclusión, se subraya la necesidad de marcos regulatorios específicos para oncología que equilibren los beneficios económicos y de equidad de los genéricos con mecanismos robustos de seguridad y supervisión clínica.
Abstract
Introduction: Oncological diseases are one of the leading causes of mortality worldwide, with the high cost of therapies representing a critical barrier for health systems. Generic drugs have emerged as an alternative to reduce costs and improve access; however, their quality, safety, and efficacy remain a subject of regulatory and clinical debate. This issue is particularly sensitive in oncology, where generics often involve cytotoxic agents, narrow Copyright: © 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/ licenses/by/4.0/). therapeutic indices, and complex formulations, all of which amplify the risks of thera peutic interchangeability. Materials and Methods: A multidisciplinary team composed of 19 experts in oncology, hepatology, gastroenterology, toxicology, endocrinology, and pharmacology was convened based on established academic contributions, clinical exper tise, and participation in regulatory or guideline development. Evidence was synthesized through a non-systematic narrative review of PubMed, Embase, and regional databases. Consensus recommendations were developed using a two-round Delphi process, with agreement defined as ≥75%. Results: The Delphi panel produced six key recommenda tions: (1) stricter requirements for bioequivalence and bioavailability, tailored to oncology; (2) strengthened pharmacovigilance and real-world monitoring; (3) standardized proto cols for therapeutic interchangeability, particularly for narrow therapeutic index agents; (4) active physician involvement in formulary decision-making; (5) harmonized regional regulatory frameworks, informed by FDA and EMA standards; and (6) expanded research on oncology-specific pharmacokinetic markers. While safety concerns dominated discus sions, experts also acknowledged the potential of generics to reduce costs, improve equity, and enhance the sustainability of oncology care. Conclusions: The findings underscore the need for oncology-specific regulatory frameworks that extend beyond conventional bioequivalence standards. A balance is required: cost savings and equity gains offered by generics must be matched with robust safety mechanisms, regulatory harmonization, and physician-led oversight. Future research should expand expert representation, integrate real-world data, and address biosimilars in dedicated analyses to ensure safe and equitable integration of non-innovator therapies in cancer care.
Palabras clave
Oncología , Medicamentos genéricos , Bioequivalencia , Seguridad farmacológica , Regulación sanitaria
Keywords
Generic drugs , Oncology , Bioequivalence , Regulation , Safety and efficacy , Delphi consensus
