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US regulatory head, FDA, approved the first biotech drug, by name Zarxio (filgrastim-sndz). It is the first biosimilar product approved in the United States. Zarxio will be used in the treatment of diseases such as cancer, leukemia, neutropenia and to individuals undergoing chemotherapy. Zarxio is the biosimilar version of an existing medication called Neupogen, made by Amgen. It was approved in Europe in 2009 as Zarzio but has not been used in the United States, as a regulatory pathway for biosimilars was missing in US.
Biosimilars will provide access to important therapies for patients who need them. – Margaret Hamburg, FDA Commissioner
Source: Biotecnika Magazine- Issue April 2015
Shekhar Suman is a Serial Entrepreneur and the Co-Founder of Biotecnika. Magazine is a way he wants to recraft the way industry opines and expresses its views. With years of experience under his belt, he captains the ship with prudence and perfection. He is the chief-editor of Biotecnika Magazine and a big inspiration to the bio-community.
I guess USA has also now moved onto the use of biosimilars! Way to go!
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