FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Amgen Brings Suit Against Yet Another Neulasta Biosimilar Maker: Mylan

Oct. 5, 2017
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Amgen leveled new biosimilar patent infringement litigation against Mylan, after the generics manufacturer submitted an FDA application for its version of the company’s Neulasta (pegfilgrastim) therapy earlier this year.

Amgen claimed that Mylan and its subsidiaries violated two Neulasta patents covering methods for manufacturing and purifying the therapy’s proteins. Neulasta stimulates white blood cell growth, and is used to prevent infections in cancer patients who have undergone immune-suppressant chemotherapy.

Filed in a western Pennsylvanian federal court, the complaint also claims that Mylan provided Amgen a copy of its aBLA that was less complete than the application provided to the FDA — as part of the “patent dance” exchange of information required by federal law.

Mylan locked out Amgen staff from saving, copying, annotating or printing a web-based version of its application, the complaint said, and many of the text, picture and spreadsheet documents were not viewable. Amgen contrasted this with the increased functionality of the electronic common technical document format used by the FDA.

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