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USFDA to give observations on Biocon's Pegfilgrastim drug on June 4

Updated : June 05, 2018 01:14 PM IST

By June 4, US Food and Drug Administration (FDA) will give their opinion on Biocon-Mylan's application for biosimilar Pegfilgrastim.

The drug is used in US for building white blood cells in cancer treatment. The US market size of Pegfilgrastim is $3.9 billion.

A biosimilar drug is the most similar version of an existing drug while a generic drug is an exact copy of an existing drug.

A biosimilar is only the closest version of a biologic drug as they are made from living organisms such as yeast or proteins and hence cannot be exactly replicated like the chemical structure of generic drugs.

About 30% of drug sold globally currently are biopharma drugs. In the US alone, 40% of prescription drugs spending is on biologic drugs.

It is the second application by Biocon with regards to the biosimilar space.

If USFDA gives nod for Pegfilgrastim, it will be the second biosimilar that Biocon has received an approval in couple of months.

Earlier, USFDA had issued a few observations on Biocon's Bangalore facility in a pre-approval inspection, which had taken place a couple of months ago.
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