Author(s):
Nandini Jaynarayan Tiwari, Kantilal B. Narkhede, Anuradha Prajapati, Sachin B. Narkhede, Shailesh Luhar
Email(s):
njaytiwari@gmail.com
DOI:
10.52711/2231-5659.2025.00026 
Address:
Nandini Jaynarayan Tiwari1*, Kantilal B. Narkhede, Anuradha Prajapati, Sachin B. Narkhede, Shailesh Luhar
Department of Pharmaceutics, Smt. B.N.B. Swaminarayan Pharmacy College, Gujarat Technological University, Salvav, Vapi, Gujarat.
*Corresponding Author
Published In:
Volume - 15,
Issue - 2,
Year - 2025
ABSTRACT:
This review looks at how biosimilars and biologics have changed throughout time, highlighting their vital function in contemporary treatments and the legal frameworks that control their advancement. Complex chemicals called biologics are formed from living things. As the patents on many original products expire, very similar versions of biologics known as biosimilars appear to improve patient access and lower healthcare costs. Biosimilars can be safely incorporated into treatment regimens and also thanks to regulatory approval procedures run by organizations like the FDA and EMA, which emphasize in proving safety, effectiveness, and immunogenicity through exacting analytical techniques. However, obstacles to wider adoption include patient views of safety and efficacy, physician approval, and shifting market dynamics. Concerns regarding product quality and consistency can also arise due to the intricacy of biologic manufacturing. This study attempts to give a thorough summary of current scientific developments, market trends, and regulatory changes while emphasizing continuous initiatives to inform patients and healthcare professionals about the advantages of biosimilars. In addition to having the potential to lower treatment costs, the effective use of biosimilars encourages biologic therapy innovation and opens the door to a more sustainable healthcare future. Furthermore, biosimilars can fulfill their potential in improving treatment affordability and accessibility for a range of patient populations.
Cite this article:
Nandini Jaynarayan Tiwari, Kantilal B. Narkhede, Anuradha Prajapati, Sachin B. Narkhede, Shailesh Luhar. Biologics and Biosimilars: Navigating Production, Approval, Applications and Challenges. Asian Journal of Research in Pharmaceutical Sciences. 2025; 15(2):167-1. doi: 10.52711/2231-5659.2025.00026
Cite(Electronic):
Nandini Jaynarayan Tiwari, Kantilal B. Narkhede, Anuradha Prajapati, Sachin B. Narkhede, Shailesh Luhar. Biologics and Biosimilars: Navigating Production, Approval, Applications and Challenges. Asian Journal of Research in Pharmaceutical Sciences. 2025; 15(2):167-1. doi: 10.52711/2231-5659.2025.00026 Available on: https://ajpsonline.com/AbstractView.aspx?PID=2025-15-2-11
REFERENCES:
1. Mudavath Shyamala. A comprehensive review on biosimilars. World Journal of Pharmaceutical Research. 2021.
2. American Cancer Society. Understanding biologic and biosimilar drugs. Retrieved October 9, 2024, from https://www.fightcancer.org/policy-resources/understanding-biologic-and-biosimilar-drugs.
3. Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011 Mar 15:1-1.
4. Bourgoin AF, Nuskey BE. An outlook on US biosimilar competition. New York: Thomson Reuters. 2013 Apr. Drugs Today 49: 399-410.
5. Mueller H. Patenting of Biosimilars. Intel Prop Rights. 2014; 2: e106.
6. Kaida-Yip F, Deshpande K, Saran T, Vyas D. Biosimilars: Review of current applications, obstacles, and their future in medicine. World Journal of Clinical Cases. 2018 Aug 8; 6(8):161.
7. Pipalava P, Patel R, Mehta M, Dahiya M, Singh I, Jose V. An update on the animal studies conducted for biosimilar approvals–Regulatory requirement vs actual scenario. Regulatory Toxicology and Pharmacology. 2019 Oct 1; 107: 104415.
8. EuropaBio, Safe Biologics. ASBM European physician’s survey on biosimilars: key findings on knowledge, naming, traceability and physicians’ choice. (2013).
9. Isaacs J, Gonçalves J, Strohal R, Castañeda-Hernández G, Azevedo V, Dörner T, McInnes I. The biosimilar approval process: how different is it? Considerations in Medicine. 2017 Nov 1; 1(1):3-6.
10. Blandizzi C, Meroni PL, Lapadula G. Comparing originator biologics and biosimilars: A review of the relevant issues. Clinical Therapeutics. 2017 May 1; 39(5): 1026-1039.
11. Janani S, Manikandan K, Kamaraj R. Overview of Biosimilars. Research Journal of Pharmacy and Technology. 2018; 11(11): 5152-5158.
12. Popat S. Kumbhar, Tejaswini P. Jadhav, Swapnil S. Chopade, Tejas T. Gavade, Rushikesh C. Sorate, Tejaswini U. Shinde, Pratik P. Maske, John I. Disouza, Arehalli S. Manjappa. Microneedles: An Advanced approach for Transdermal Delivery of Biologics. Asian Journal of Pharmaceutical Research. 2021; 11(1):46-54.
13. Almaaytah Ammar. A Review of the Non-clinical and Clinical Requirements for the performance of a comparability exercise for Bevacizumab biosimilars. Research Journal of Pharmacy and Technology. 2023; 16(7): 3499-3506.
14. Shire, Steven J. Formulation and manufacturability of biologics. Current Opinion in Biotechnology. 2009 Dec 1; 20(6):708-714.
15. Tanaji D. Nandgude, Priyajit S. Hasabe, Anuja K. Kolsure. Clinical Features and Treatment of Rheumatoid Arthritis: A Review. Research Journal of Pharmacy and Technology. 2018; 11(12): 5701-5706.
16. Rathore A. Guidelines on similar biologics: regulatory requirements for marketing authorization in India. PDA Journal of Pharmaceutical Science and Technology. 2012 Sep 1; 66(5):393.
17. Emmanouilides CE, Karampola MI, Beredima M. Biosimilars: Hope and Concern. Journal of Oncology Pharmacy Practice. 2016 Aug; 22(4):618-624.
18. Misra M. Biosimilars: current perspectives and future implications. Indian Journal of Pharmacology. 2012 Jan 1; 44(1):12-14.
19. Rajput Bane Singh. A Comparison of US, Europe, Japan and India Biosimilar Regulations. Int. J. Drug Dev. and Res. 2013; 5(2):35-39.
20. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London, UK: European Medicines Agency. 2006. http://www.emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf.