Comparative Study on the Stability of Biosimilar and Biologic Drugs

DOI: https://doi.org/10.63345/ijrmp.v13.i6.2

Tanya Joshi

Himachal Pradesh, India

Abstract

The evolution of biopharmaceuticals has significantly advanced therapeutic options, with biologic drugs leading the market for treating chronic and life‐threatening conditions. In parallel, biosimilars have emerged as cost-effective alternatives, promising similar therapeutic outcomes while expanding access to treatment. Stability, a critical quality attribute of these drugs, affects not only efficacy and safety but also regulatory approval and market performance. This study presents a comparative analysis of the stability profiles between biosimilar and originator biologic drugs. We have conducted a literature review up to 2021, detailed a statistical evaluation of stability data, and discussed factors influencing stability such as formulation differences, manufacturing processes, and storage conditions. Our findings indicate that while biosimilars generally adhere to strict regulatory guidelines to match their reference biologics, subtle variations in degradation profiles can emerge under stress testing conditions. This manuscript outlines the methodologies used, presents statistically significant data, and concludes with recommendations for further research and quality improvement measures.

Keywords

Biosimilars; Biologics; Stability; Drug Formulation; Pharmacokinetics; Quality Assurance; Statistical Analysis.

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