A NOVEL PERSPECTIVE OF BIOSIMILARS IN HEALTHCARE

Authors

  • Dhanalakshmi S. Sree Abirami College of Pharmacy-Coimbatore-21
  • Sangavi S. Sree Abirami College of Pharmacy-Coimbatore-21
  • Vigneshwaran L. V. Corresponding Author, Sree Abirami College of Pharmacy-Coimbatore-21
  • Senthil Kumar M. Sree Abirami College of Pharmacy-Coimbatore-21

Keywords:

Biosimilars, Competitive, European Medicines Agency

Abstract

The major goal of biosimilars is to lower healthcare costs associated with biologics use and thereby enhance healthcare access. The bioequivalence technique is not deemed appropriate for the approval of biosimilars, unlike small-molecule generics. Biosimilars are approved based on a step-by-step comparison with the Reference Biologic, beginning with a full physicochemical and biological characterization. The scope and character of the required non-clinical in vivo and clinical research are determined by the amount of evidence gathered in the preceding steps.

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Published

2022-04-14

How to Cite

Dhanalakshmi S., Sangavi S., Vigneshwaran L. V., & Senthil Kumar M. (2022). A NOVEL PERSPECTIVE OF BIOSIMILARS IN HEALTHCARE . British Journal of Global Ecology and Sustainable Development, 3, 55–61. Retrieved from http://journalzone.org/index.php/bjgesd/article/view/41

Issue

Vol. 3 (2022)

Section

Articles

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