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Adello’s Filgrastim Biosimilar Faces Infringement Lawsuit And Potential Regulatory Delay

 
• By Sue Sutter

US FDA user fee date for privately held company’s 351(k) application referencing Amgen’s Neupogen may have passed without word of a regulatory action; Amgen sued Adello in March alleging infringement of 17 patents covering the innovator product.

Adello Biologics may be facing regulatory as well as legal hurdles in its bid to bring a proposed biosimilar of Amgen Inc.’s Neupogen (filgrastim) to the US market.

The user fee date for the company’s 351(k) application appears to have passed without public disclosure of an FDA regulatory action

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