Biosimilar approval and checkpoints

Short Communication

Author Details : Sunil Chaudhry*, Avisek Dutta

Volume : 7, Issue : 2, Year : 2021

Article Page : 141-145

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Biologic drugs and subsequently developed biosimilars treat chronic inflammatory autoimmune conditions such as rheumatoid or psoriatic arthritis, ankylosingspondylitis, crohn's disease, ulcerative colitis, and psoriasis. Biologics can target the cancer in a specific way and may work synergistically with chemotherapy to improve outcome. It is expected that in the next five years, 50% of biological products will originate from biotechnology. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination. There are no expected clinically meaningful differences in efficacy and safety between a biosimilar and the biologic drugs which are authorized for sale.
The global market for is dominated by oncology (nearly 39% share) whereas the total market size is expected to reach nearly 70 billion by 2025.
Biosimilar are generally marketed at prices 25 to 40 percent below original branded . The number of  approved by US FDA are nearly 30. There are about 25 top global manufacturers of . Many Domestic companies in India are making strong presence even in regulated markets..
Bioslogics Price (BPCIA) guidelines in the United States (US), mention that a biosimilar can be designated as “interchangeable”, whereby it may be substituted for the reference product (original biological drug).

Keywords: Biosimilar, Biologic, Biosimilar market, Pharmacovigilance, Regulatory Knowledge

How to cite : Chaudhry S, Dutta A, Biosimilar approval and checkpoints. J Prev Med Holist Health 2021;7(2):141-145

Copyright © 2021 by author(s) and J Prev Med Holist Health. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License (

Article History

Received : 26-07-2021

Accepted : 02-09-2021

Available online : 04-12-2021

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