Biosimilars: Past, Present, and Future
Volume 5, Issue 4, December 2019, Pages: 60-66
Received: Oct. 18, 2019;
Accepted: Nov. 7, 2019;
Published: Nov. 21, 2019
Views 542 Downloads 135
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
Follow on us
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.
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
Abu Syed Md. Anisuzzaman,
Biosimilars: Past, Present, and Future, Biomedical Sciences.
Vol. 5, No. 4,
2019, pp. 60-66.
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.
Bulletin of the World Health Organization (WHO). Regulatory evaluation of biosimilars throughout their product life-cycle. https://www.who.int/bulletin/volumes/96/4/17-206284/en/ Assessed on: 08 August 2019.
EMA Biosimilar medicines: Overview. https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview Assessed on 09 August 2019.
US-FDA: Biosimilar and Interchangeable Products. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#biosimilar. Assessed on 09 August 2019.
Quintiles IMS: The impact of biosimilar competition in Europe 2017 (last update 5 May 2017). http://ec.europa.eu/docsroom/documents/23102/attachments/1/translations/en/renditions/pdf Accessed on 05 August 2019.
US-FDA Biosimilar Product Information. http://www.fda.gov/grugs/biosimilars/biosimilar-product-information. Accessed 05 August 2019.
EMA Biosimilar medicines: Development and Approval of Biosimilar. https://www.ema.europa.eu/en/humanregulatory/overview/biosimilar-medicines-overview Assessed on 10 August 2019.
Biosimilar: An overview. Bhupinder Singh Sekhon, Vikrant Saluja, Drovepress: Biosimilars 2011:1 1–11. https://www.dovepress.com/biosimilars-an-overview-peer-reviewed-article-BS
Nature: Bring on the biosimilars. (Outline May 2019), https://www.nature.com/articles/d41586-019-01401-5. Assessed on 08 August 2019.
EMA Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. https://www.ema.europa.eu/en/documents/scientific guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf, Assessed on 15 August 2019.
Comparing Originator Biologics and Biosimilars: A Review of the Relevant Issues. Corrado Blandizzi, et al, Journal of Clinical Therapeutics (2017), http/dx.doi.org/10.1016/j.clinthera.2017.03.014.
Biosimilars: pharmacovigilance and risk management, Leyre Zuniga Ph.D. and Begona Calvo Ph.D. Pharmacoepidemiology and Drug Safety, 2010; 19: 661–669. Published online 7 May 2010 in Wiley Inter Science (www.interscience.wiley.com) DOI: 10.1002/pds.1948.
Drug development: ‘Biosimilar’ drugs poised to penetrate market, News in focus, Nature| Vol 468|4 November 2010.
An introduction to safety issues in Biosimilars/follow-on Biopharmaceuticals, Filiz Hincal, J Med CBR Def | Volume 7, 2009.
An introduction to biologics and biosimilars. Part-II: Subsequent entry biologics: Biosame or Biodifferent? Peer-Reviewed, Leigh Revers, MA, DPhil; Eva Furczon, HBSc, MBiotech, C P J / R P C • July / August 2 0 1 0 • Vol 1 4 3, No. 4, P184-191.
Biosimilars: Opportunity or Cause for Concern? Simon D. Roger and Ashraf Mikhail, J Pharm Pharmaceut Sci (www. cspsCanada.org) 10 (3): 405-410, 2007.
Commentary, Biosimilars: it’s not as simple as cost alone. S. D. Roger, MD FRACP and D. Goldsmith_ MA FRCP, Journal of Clinical Pharmacy and Therapeutics (2008) 33, 459–464.
Biosimilars: How similar or dissimilar are they? Simon D Roger, Nephrology 2006; 11, 341–346.
US-FDA: Biosimilar Development, Review, and Approval. https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval Assessed on 16 August 2019.
TGA-Australia, Evaluation of biosimilars, https://www.tga.gov.au/sites/default/files/pm-argpm-biosimilars-150420_1.pdf Assessed on 16 August 2019.
About Biosimilar manufacturing, https://www.biosimilardevelopment.com/solution/biosimilar-manufacturing, Assessed on 17 August 2019.