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Petition Piles Pressure On FDA Over Biosimilar Suffix

 
• By Dave Wallace

A citizen petition filed by biosimilars industry veteran Sarfaraz Niazi has once again urged the FDA to reconsider its approach on biosimilar naming, along with suggesting changes to language used by the regulator to describe biosimilars.

Suffix
Suffixes To Biosimilar Names Are Once Again In The Spotlight • Source: Shutterstock

The US Food and Drug Administration (FDA) should modify its latest biologics naming guidance to remove the need to add a four-letter random suffix to biosimilar names and should amend its definition of biosimilars to clarify the nature of such drugs, thereby removing “impediments to the adoption of biosimilar products”, according to a citizen petition filed by biosimilars industry veteran Sarfaraz Niazi.

Niazi – who is the founding chairman of Adello Biologics, Karyo Biologics and consultancy Pharmaceutical Scientist – urges the agency...

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