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FDA to Review Sandoz Biosimilar of Neulasta

Sandoz’s pegfilgrastim shows efficacy and safety comparable to Amgen product

The FDA has agreed to review Sandoz’s application to produce a biosimilar of pegfilgrastim (Neulasta, Amgen), a recombinant human granulocyte colony-stimulating factor (G-CSF) drug that produces white blood cells to fight infection in cancer patients.

The agency accepted Sandoz’s biologics license application (BLA) under the 351(k) pathway. Sandoz is seeking approval for the same indication as the reference product. Pegfilgrastim is used to help reduce the chance of infection due to a low white blood cell count in patients with nonmyeloid cancer who receive chemotherapy that can cause fever and a low blood cell count (febrile neutropenia).

Sandoz believes that the evidence in its submission, including three pivotal clinical trials — one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients — will demonstrate that the proposed biosimilar is highly similar to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product's indication.

The pegfilgrastim biosimilar is produced by Germany’s Sandoz, the generic pharmaceuticals division of Swiss drug company Novartis International. Biosimilars aim to copy their original counterparts but cannot duplicate them exactly. To be approved by the FDA, biosimilars must show comparability with no adverse side effects.

In the U.S., the incidence of febrile neutropenia is estimated to be more than 60,000 cases a year, accounting for nearly eight cases per 1,000 cancer patients. Approximately 1.6 million people per year in the U.S. develop nonmyeloid cancer.

Source: Sandoz, November 18, 2015.

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