Novarce Neulasta biosimilars are approved by the FDA

, Novarma's Sanders biosimilar Ziextenzo has been approved by the FDA and is scheduled to go on sale this year.The FDA refused to approve Ziextenzo in July 2016, and in April, Sanders resubmitted a new drug application, adding other trial data from key drug dynamics studies.It's worth noting that Ziextenzo is the 8th biosimilar approved by Sanders worldwide, and the company is preparing for Ziextenzo's launch, the exact price of which has not been disclosed.Ziextenzo's original drug was Neulasta, a "whitening" drug used to increase the number of white blood cells in patients, and the active drug was pegfilgrastim, a recombinant human granulocyte macrophage collection stimulation factor (G-CSF). G-CSF clinical use is mainly used to prevent and treat leukocyte reduction caused by tumor radiotherapy or chemotherapy, to treat myeloid dysfunction and bone marrow growth syndrome, to prevent possible infection complications of leukocyte reduction, and to accelerate the recovery of infection-induced neutral granulocyte reduction. After radiotherapy or chemotherapy, tumor patients often experience symptoms such as reduced white blood cells and reduced anti-infectability. Therefore, clinically, "whitening drugs" are often used to increase the number of white blood cells in patients.Neulasta is a super-heavy product with global sales of $4.56 billion in 2017, 87% of which came from the U.S. market. Neulasta's core patents expire in the U.S. market in June 2015 and in Europe in August 2017. In June and November 2018, Neulasta's biosimilars, Mylan's Fulphila and Coherus BioSciences' Udenyca, were approved by the FDA. Now that Ziextenzo is in the market, competition in this area will intensify.Since the launch of these Neulasta generics, the impact on Agusta has been clear. Neulasta's sales fell 32 per cent to $711m in the third quarter, according to the latest figures. (
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