Biosimilars: Sandoz Pegfilgrastim Review, Amgen Adalimumab Launch Extended To 2018

Sandoz needs to do another study to satisfy FDA, while Amgen says it faces a slow pace of patent litigation with AbbVie.

DNA

There's still only one biosimilar on the US market, but the third quarter earnings calls this year may have marked the point where updates about them became routine, with firms discussing the products just as they would any pipeline project or potential competitor.

Novartis AG, for one, confirmed during its third quarter earnings call that its application for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) will be tied up at FDA until at least sometime in 2018. Sandoz Inc., a unit of Novartis, filed the application in September 2015 and in July reported that it had received a complete response letter from FDA

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