Sandoz bags FDA’s approval for long-acting oncology supportive care biosimilar Ziextenzo

Sandoz Tuesday said it got approval from US Food and Drug Administration for its biosimilar Ziextenzo, which is in particularly significant since Sandoz short-acting filgrastim Zarxio is the first biosimilar to surpass its reference biologic in US market share.

Sandoz is now the first and only company to offer physicians in the US the choice between a long- and short-acting biosimilar filgrastim treatment to best suit the individual needs of tens of thousands of patients undergoing chemotherapy. With four US approved biosimilars, Sandoz is committed to expanding patient access, increasing healthcare savings and fueling innovation.

Carol Lynch, President of Sandoz Inc, said: “When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy .The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio – the leading filgrastim by market share in the US – including consistent product supply and reliable patient services.”