Abstract

BIOSIMILARS AT THE CROSSROADS OF INNOVATION AND ACCESSIBILITY: A COMPREHENSIVE CONTEMPORARY REVIEW FOR ADVANCING GLOBAL PHARMACOTHERAPY

Devansh Mehta*

ABSTRACT

Biosimilars represent one of the most consequential developments in modern biopharmaceutical science, emerging as strategic instruments for expanding access to high-value biological therapies. As global healthcare systems grapple with escalating costs, biosimilars offer a scientifically robust and economically sustainable alternative to reference biologics. Yet their developmental pathways, regulatory expectations, clinical adoption, and societal impact continue to evolve. This review offers a detailed, research-driven appraisal of biosimilars, incorporating analytical foundations, regulatory divergences, immunogenicity considerations, manufacturing complexities, economic repercussions, and future trajectories. It seeks to provide an authoritative perspective for academia, industry, and regulatory stakeholders committed to shaping the next era of biological therapeutics.

Keywords: Biosimilars, Clinical Research, Clinical Trials, Reglatory Affairs, Pharmaceutical Industry.