Equitable Access to Biosimilars: An Overview

Khurram Rehman, Nadeem Irfan Bukhari, Zaheer-Ud-Din Babar

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The biosimilars are highly similar to the reference biological medicinal products and provide an alternative for biologics. Many of the patents of biologics are near expiry and this may lead to increase in market share of biosimilars. The biosimilar market is expanding rapidly and although they are similar to their reference biologics in pharmacological activity, safety, and quality; they are cheaper in terms of cost. However, barriers exist for patients accessing these medicines. This chapter reviews the literature around those barriers and provides solution toward providing affordable access to biosimilars. The barriers related to accessing biosimilars include the time-consuming and complex development of biologics, stringent legislation, and registration process as well as healthcare professionals knowledge about biosimilars and litigation in the United States. There is a need to overcome those barriers and work toward producing uniform regulatory guidelines for the approval of biosimilars. The steps like these would certainly help to promote access and affordability of biosimilars for the masses.
Original languageEnglish
Title of host publicationEquitable Access to High-Cost Pharmaceuticals
EditorsZaheer-Ud-Din Babar
PublisherElsevier
Chapter9
Pages129-142
Number of pages14
Edition1st
ISBN (Electronic)9780128119624
ISBN (Print)9780128119457
DOIs
Publication statusPublished - 21 Feb 2018

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Rehman, K., Bukhari, N. I., & Babar, Z-U-D. (2018). Equitable Access to Biosimilars: An Overview. In Z-U-D. Babar (Ed.), Equitable Access to High-Cost Pharmaceuticals (1st ed., pp. 129-142). Elsevier. https://doi.org/10.1016/B978-0-12-811945-7.00009-9