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Can Biosimilars Compete With ‘Unbranded Biologics’ In The US Market?

 
• By Derrick Gingery

Biologics with their brand name dropped from the label could become the alternative to an ‘authorized biosimilar,’ which is not allowed under the law.

Insulin vials with synringe
Two sponsors already are marketing insulin products as 'unbranded biologics.' • Source: Shutterstock

The US Food and Drug Administration has an approval pathway in mind for unbranded biologics, but sponsors should not send in their applications unannounced.

An unbranded biologic is an approved biologic marketed under the BLA of its brand product, but without the proprietary name on the label

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