European Journal of Biomedical and Pharmaceutical Sciences

BIOSIMILARS FOR CANCER CARE: REGULATORY PATHWAYS, CLINICAL EVIDENCE, AND THE ROLE OF FILGRASTIM AND PEGFILGRASTIM

Sampath Sri Venkata Sai Kumar Maddula, Swetha Vegesna*, Naga Datta Sasi Mrudula Kothapalli, Mishall Masa

ABSTRACT

Biosimilars are biopharmaceuticals designed to demonstrate a high degree of similarity to reference biologics, guaranteeing no significant differences in safety, purity, or effectiveness. Due to the intricate nature of biologics, the development of biosimilars demands sophisticated analytical characterization, functional validation, and confirmatory preclinical and clinical trials. In contrast to small-molecule generics, proving biosimilarity involves more than just chemical equivalence; it also encompasses similar pharmacokinetic, pharmacodynamic, and immunogenicity profiles. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have implemented rigorous approval processes, bolstered by long-term monitoring of drug effects, to ensure therapeutic reliability and patient safety. Oncology is a significant field for the adoption of biosimilars. Biosimilars for supportive care medications like filgrastim and pegfilgrastim have demonstrated comparable efficacy and safety to their original biologics in preventing neutropenia caused by chemotherapy. Their incorporation into cancer treatment has lowered costs, improved access in both advanced and developing areas, and supported more sustainable approaches to cancer management.  This review brings together the evolution, structural and functional assessment, regulatory frameworks, manufacturing aspects, and clinical verification of biosimilars. With an emphasis on applications in oncology, particularly filgrastim and pegfilgrastim, the data highlights their crucial role in enhancing sustainable healthcare and increasing access to high-quality cancer therapies globally.

Keywords: Biosimilars, Pharmacokinetics, Pharmacodynamics, Monoclonal antibodies, Interchangeability.