Sandoz tries again with biosimilar Neulasta in the USA

3 April 2019

Novartis’ (NOVN: VX) USA-based generics division Sandoz has resubmitted a US application for a biosimilar version of pegfilgrastim.

The product, which references Amgen’s (Nasdaq: AMGN) Neulasta, is already approved in Europe, where it is marketed as Ziextenzo.

The firm presented positive Phase III data for the candidate in 2015, showing the therapy met its safety and efficacy goals, but was rebuffed by the US regulator in June 2016.

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