FDA News

FDA approves Ziextenzo, biosimilar to pegfilgrastim

The FDA approved pegfilgrastim-bmez, a biosimilar pegfilgrastim.

Pegfilgrastim-bmez (Ziextenzo, Sandoz) — a long-acting supportive care biosimilar — is indicated to reduce incidence of infection as manifested by febrile neutropenia for patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The biosimilar’s reference product, pegfilgrastim (Neulasta, Amgen) is approved for this indication, as well as to increase survival among patients acutely exposed to myelosuppressive doses of radiation.

Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product. The pre-approved agents are called reference products.

Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety. Only small differences in clinically inactive components are allowable with biosimilar products.

Pegfilgrastim-bmez has been approved and marketed in Europe since 2018.

More than 60,000 people with cancer in the United States are hospitalized with evidence of neutropenia each year, and more than 4,000 deaths occur as a result.

The FDA previously approved Sandoz’s short-acting filgrastim biosimilar, filgrastim-sndz (Zarxio).

“When a [person with cancer] with febrile neutropenia gets an infection, it can have serious consequences, such as delays or dose reductions of chemotherapy,” Carol Lynch, president of Sandoz, said in a company-issued press release. “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 ... Zarxio.”

The FDA approved pegfilgrastim-bmez, a biosimilar pegfilgrastim.

Pegfilgrastim-bmez (Ziextenzo, Sandoz) — a long-acting supportive care biosimilar — is indicated to reduce incidence of infection as manifested by febrile neutropenia for patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The biosimilar’s reference product, pegfilgrastim (Neulasta, Amgen) is approved for this indication, as well as to increase survival among patients acutely exposed to myelosuppressive doses of radiation.

Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product. The pre-approved agents are called reference products.

Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety. Only small differences in clinically inactive components are allowable with biosimilar products.

Pegfilgrastim-bmez has been approved and marketed in Europe since 2018.

More than 60,000 people with cancer in the United States are hospitalized with evidence of neutropenia each year, and more than 4,000 deaths occur as a result.

The FDA previously approved Sandoz’s short-acting filgrastim biosimilar, filgrastim-sndz (Zarxio).

“When a [person with cancer] with febrile neutropenia gets an infection, it can have serious consequences, such as delays or dose reductions of chemotherapy,” Carol Lynch, president of Sandoz, said in a company-issued press release. “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 ... Zarxio.”