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

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.

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