Volume 5, Issue 4, December 2019, Page: 60-66
Biosimilars: Past, Present, and Future
Abdul Alim, Department of Pharmacy, University of Rajshahi, Rajshahi, Bangladesh
Ahasanul Hasan, Department of Clinical Pharmacy & Pharmacology, University of Dhaka, Dhaka, Bangladesh
Abu Syed Md. Anisuzzaman, Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, USA
Received: Oct. 18, 2019;       Accepted: Nov. 7, 2019;       Published: Nov. 21, 2019
DOI: 10.11648/j.bs.20190504.14      View  477      Downloads  125
Abstract
The expiry of patent of biologic medicines emerged the development and manufacturing of biosimilar products worldwide. A number of biologic medicines have successfully been developed and approved over the last one and half decades, enlightening the lives of patients globally. According to the European Medicines Agency (EMA), biosimilar product can be defined as a biological medicine that is highly similar to another biological medicine that has already been authorized for use. Biological medicines contain active substances from a biological source, for example, living cells or organisms (human, animals and microorganisms: bacteria or yeast) and are often manufactured by cutting-edge technology. Most of the biological medicines in current clinical use comprise of active substances made of proteins. Biopharmaceuticals contain a wide-range of products such as vaccines, immunoglobulins, monoclonal antibodies, cell and gene therapy products. The EMA led the way (well ahead of the Food and Drug Administration in the US) in evolving the biosimilar idea, and the type of science-based regulatory framework required to ensure high-quality, safe, and effective biosimilar medicines; the provisions for approval of biosimilars have been in place in Europe since the year 2005. Under these provisions, Omnitrope® (Somatropin-Sandoz-Novartis) was approved by the EMA in the year 2006 as the world’s first biosimilar medicine; the US Food and Drug Administration (US-FDA) approved ZarxioTM (Filgrastim-Sandoz) for all indications included in the reference product’s label in March 2015. ZarxioTM (Sandoz-Novartis) is the first biosimilar product approved by US-FDA.
Keywords
Biosimilars, Biologic Medicines, Biopharmaceuticals, European Medicines Agency (EMA), The US Food and Drug Administration (US-FDA), World Health Organization (WHO), Immunogenicity, Pharmacovigilance
To cite this article
Abdul Alim, Ahasanul Hasan, Abu Syed Md. Anisuzzaman, Biosimilars: Past, Present, and Future, Biomedical Sciences. Vol. 5, No. 4, 2019, pp. 60-66. doi: 10.11648/j.bs.20190504.14
Copyright
Copyright © 2019 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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