Pegfilgrastim Biosimilar Under FDA Review


The FDA has accepted Sandoz's biologics license application for its proposed pegfilgrastim biosimilar.

The FDA has accepted Sandoz’s biologics license application for its proposed pegfilgrastim (Neulasta) biosimilar.

In its submission to the FDA, the manufacturer included 3 clinical trials, which demonstrated that the proposed biosimilar is highly similar to the reference product, according to Sandoz.

Pegfilgrastim is a prescription medication used to reduce the chance of infection due to a low white blood cell count in patients with non-myeloid cancer who receive chemotherapy that can cause fever and a low blood cell count.

Approximately 60,000 cases of febrile neutropenia are reported in the United States each year, which amounts to 8 cases per 1000 cancer patients.

Around 1.6 million Americans develop non-myeloid cancer annually.

"The FDA's acceptance of our regulatory submission for biosimilar pegfilgrastim—our third biosimilar filed in the US—demonstrates our commitment to expanding patient access to biologics in the US," said Mark McCamish, head of Global Biopharmaceutical and Oncology Injectables Development at Sandoz, in a press release. "If approved, physicians will have another high-quality Sandoz treatment option for patients needing granulocyte colony-stimulating factors.

Adverse effects associated with Neulasta are bone pain in the arms and legs and spleen rupture.

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