Author(s):
Omkar Vilas Dharak, Ankita Sunil Jadhav, Shital Dattu Arkhade, Gajesh Bharat Welanjkar
Email(s):
omkardharak885@gmail.com
DOI:
10.52711/2231-5659.2025.00011 
Address:
Omkar Vilas Dharak1, Ankita Sunil Jadhav2, Shital Dattu Arkhade3, Gajesh Bharat Welanjkar4
1,3Matoshri Institute of Pharmacy College, Dhanore, Maharashtra.
2Shree Mahavir Institute of Pharmacy College, Nashik, Maharashtra.
4Vivekanand College of Pharmacy, Chembur, Mumbai, Maharashtra.
*Corresponding Author
Published In:
Volume - 15,
Issue - 1,
Year - 2025
ABSTRACT:
Biologic medications, which are produced from live organisms, have significantly transformed the treatment of several diseases by providing precise therapies that are highly effective. Biosimilars have emerged as biologically similar alternatives to biologics, which are hard and expensive to create. However, it is important to note that biosimilars are not identical to the original medications. This abstract examines the fundamental distinctions between biologics and biosimilars, with a specific emphasis on their development procedures, regulatory prerequisites, and the difficulties encountered in guaranteeing their safety, effectiveness, and interchangeability. The study also emphasises the influence having biosimilars on healthcare expenses and availability, emphasising the significance of rigorous regulatory regimes in upholding therapeutic benchmarks.
Cite this article:
Omkar Vilas Dharak, Ankita Sunil Jadhav, Shital Dattu Arkhade, Gajesh Bharat Welanjkar. Development and Regulation of Biologic Drugs – Comparison between Biologics and Biosimilars. Asian Journal of Research in Pharmaceutical Sciences. 2025; 15(1):77-0. doi: 10.52711/2231-5659.2025.00011
Cite(Electronic):
Omkar Vilas Dharak, Ankita Sunil Jadhav, Shital Dattu Arkhade, Gajesh Bharat Welanjkar. Development and Regulation of Biologic Drugs – Comparison between Biologics and Biosimilars. Asian Journal of Research in Pharmaceutical Sciences. 2025; 15(1):77-0. doi: 10.52711/2231-5659.2025.00011 Available on: https://ajpsonline.com/AbstractView.aspx?PID=2025-15-1-11
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