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THE PHARMA REVIEW
(SEPTEMBER
- OCTOBER 2013) |
Biosimilars: A Brief
Overview
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Virendra SL,
Sreedhar D, Manthan J, Pradeep M & Udupa N
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Introduction: According to USFDA Biological
products are therapies used to treat diseases and health
conditions. They include a wide variety of products like
vaccines, blood and blood components, gene therapies,
tissues, and proteins. Unlike most prescription drugs
made through chemical processes, biological products
generally are made from human and/or animal materials. A
biosimilar is a biological product that is highly
similar to an already approved biological product,
notwithstanding minor differences in clinically inactive
components, and for which there are no clinically
meaningful differences between the biosimilar and the
approved biological product in terms of the safety,
purity, and potency1.
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