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FDA Approves 24th Biosimilar, 3rd for Neulasta

Posted 05 November 2019 | By Zachary Brennan 

FDA Approves 24th Biosimilar, 3rd for Neulasta

The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s Ziextenzo (pegfilgrastim-bmez), which is the third biosimilar to be approved as competition for Amgen’s Neulasta (pegfilgrastim), which can help patients fight the risk of infection from chemotherapy.

Unlike most biosimilars approved by FDA (24 now approved, just nine launched), Sandoz said it expects to launch Ziextenzo, which was previously rejected by FDA, before the end of the year. The other two pegfilgrastim biosimilars, from Mylan and Coherus, have previously launched at a 33% price discount and gained about 20% US market share combined, according to Bernstein analyst Ronny Gal.

Sandoz’s pegfilgrastim biosimilar also received European Commission approval in November 2018. Three Neulasta biosimilars have now captured about 35% of the market in the EU, according to Bernstein.

First approved in 2002, Amgen said in its most recent earnings report that Neulasta sales have fallen by 32% compared to last year because of biosimilar competition.

According to a recent ICER report, Neulasta’s net price rose by about 13% between Q4 2016 and Q4 2018, which was not supported by new clinical evidence and which resulted in an estimated increase in spending of $489 million.

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