Deciphering the US Regulatory Framework: Comparison Between Oncology Biosimilars and Reference Biologics.

Abstract

Biological oncology agents are vital in cancer care, but their exorbitant expenses present obstacles for patients, families, healthcare professionals, and insurance providers. The advent of biosimilars represents a transformative solution, offering more affordable alternatives after the expiration of biologics patents. Biosimilar agents, similar to biological agents in structure, function, safety, and immunogenicity, enhance healthcare accessibility, improve outcomes, and reduce costs. Thus, the safety of biosimilars in clinical settings is of utmost importance. This review provides a detailed overview of the United States (US) regulatory framework for biosimilars along with a comparative analysis of Food and Drug Administration (FDA) approved biosimilar products. The FDA's "Biosimilar product information" database and "FDA's Purple Book" database were used to retrieve data on approved biosimilars and reference biologicals respectively. The study compares biosimilars and their reference products, examining their physiological action, pharmacokinetics, indications, adverse reactions, and immunogenicity test results and concludes that biosimilars do not have significant variations from their reference biologic products. This analysis will offer critical insights for medical practitioners, clinicians, and patients. It empowers stakeholders to make informed decisions, assessing whether biosimilars offer an equivalent level of safety compared to their reference products. Biosimilars are endorsed as credible substitutes for originator biologics, improving accessibility and affordability in cancer care, and benefiting patients and healthcare systems.