Apotex challenges Amgen blockbuster Neulasta

As the FDA works in concert with the court system to interpret and implement legislation establishing a pathway for biosimilars, Apotex has submitted an application for pegfilgrastim, a copycat version of Amgen's $3.5 billion blockbuster Neulasta.


The white cell booster for patients on chemotherapy is a long-acting version of Neupogen (filgrastim), which Sandoz is looking to knock off with the first biosimilar application submitted to FDA. Apotex becomes the third supplicant lining up to navigate the biosimilar process. Celltrion previouslyfiled a proposed version of J&J's Remicade.

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