A new biosimilar to the branded cancer infection drug pegfilgrastim (Neulasta, Amgen) will soon be available in the United States.
FDA cleared Sandoz’s pegfilgrastim-bmez (Ziextenzo) to decrease the incidence of infection as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
“Physicians in the US will have a new treatment option to best suit individual needs of the tens of thousands of patients undergoing chemotherapy who need pegfilgrastim,” Sandoz said in a prepared statement for FormularyWatch. “We are committed to ensuring patient access to Ziextenzo as soon as possible this year.”
The wholesale acquisition cost (WAC) for Ziextenzo is $3,925, around 37% less than Neulasta.
“Biosimilars could save the U.S. as much as $54 billion over the next decade. With every biosimilar we develop, our goals are to expand access to these important medicines and reduce healthcare cost spending so savings are passed along to patients,” according to the statement.
Febrile neutropenia is one of the most serious side effects of chemotherapy. A study has shown that each year in the US, more than 60,000 cancer patients are hospitalized with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result, Sandoz said in a statement.
With the new approval, Sandoz will provide both long- and short-acting biosimilar filgrastim options to US physicians and patients, “allowing them the opportunity to decide on the most suitable treatment based on individual patient needs,” the spokesperson said.
Sandoz’s short-acting biosimilar filgrastim-sndz (Zarxio) is the leading filgrastim by market share in the US, the spokesperson added.