Sandoz Receives FDA Approval for Ziextenzo

Recently the US Food and Drug Administration has approve a biosimilar by Sandoz called Ziextenzo. The biosimilar pegfilgrastim is already approved and is sold across Europe since 2018. Sandoz now intends to launch it in the US market within the current year.

The rising incidence of cancer and cancer related complications have fuelled the demand for novel therapeutics around the world. This, together with funding from leading institutions, is boosting several research and development initiatives around the world.

The drug in question is intended to bring down the incidence of infection caused due to febrile neutropenia or low white blood cell count. This happens mainly among patients with non-myeloid malignancies, who are currently receiving anti-cancer drugs.

It was revealed by the Novartis division that the FDA approval was based on three factors which included clinical, preclinical, and analytical research. Furthermore, it included information sourced via three pivotal methods, which included pharmacodynamics and pharmacokinetics study. The study revealed similarly between all three comparisons, with no clinical differences with regards to the immunogenicity and safety among treatment groups.
Serious consequences can happen if a cancer patient with febrile neutropenia gets infected. It can cause delays is dose recognition of chemotherapy. With the approval of the biosimilar Sandoz has successfully expanded its oncology portfolio, whilst offering a supportive and long-acting biosimilar option to physicians.

Every year the US witnesses nearly 60,000 cases of hospitalization of cancer patients with neutropenia evidence, which may include infection or high fever. This infection also causes nearly 4000 deaths every year. Therefore the approval of Sandoz’ biosimilar is welcome as it promises to best suit an increasing number of patients undergoing chemotherapy. Furthermore it is important to note here that following the approval, Sandoz is currently the sole company providing an option between a short and long acting biosimilar filgrastim treatments in the United States.

Dr.James Robinson

Dr.James Robinson, MD, MS is an Associate Professor of Epidemiology and Medicine DescriptionThe Icahn School of Medicine at Mount Sinai is a private graduate medical school in Manhattan, New York City, where he serves as a founding co-Director of the Center for Drug Safety and Effectiveness. He is a practising general internist and pharmacoepidemiologist and is internationally recognised for his research examining prescription drug utilisation. Dr.James Robinson is the author of over a hundred scientific articles and book chapters, is a frequent speaker on health care issues and has served on numerous editorial and advisory boards. Email Id:

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