Optimization of the Use of Generic Medications in Oncology: Improving Safety and Therapeutic Quality

Autor

Andrés F. Zuluaga
Carlos Vargas
Daniel F. Alarcón Cano
Diana Marcela Escobar Cárdenas
Diego Gómez Abreo
Fernando Ayala
Hugo Castro-Salguero
Jorge Mario Ortiz
Juan Ignacio Marín
Leonardo J. Rojas-Melo
Marcela Urrego
Marie Claire Berrouet Mejía
Mauricio Lema-Medina
Nelson Belalcázar Carvajal
Pilar Milla Bernabé
Rafael E. Niño Velasco
Ruth Osorio Estévez
Óscar Beltrán

Resumen

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 therapeutic indices, and complex formulations, all of which amplify the risks of therapeutic 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 expertise, 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 recommendations: (1) stricter requirements for bioequivalence and bioavailability, tailored to oncology; (2) strengthened pharmacovigilance and real-world monitoring; (3) standardized protocols 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 discussions, 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.

autores

http://vivoweb.org/ontology/core#FacultyMember
Calderón Ospina, Carlos Alberto

fecha de publicación

2025-11-1

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Salud y bienestar

Edición

14

VIVO
VIVO

Optimization of the Use of Generic Medications in Oncology: Improving Safety and Therapeutic Quality Artículo académico

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