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Regulatory submission for Sandoz’ proposed biosimilar pegfilgrastim accepted by FDA

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Proposed biosimilar pegfilgrastim filing is the second of ten regulatory filings planned over the next three years

Sandoz, a Novartis company and the global leader in biosimilars, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Neulasta (pegfilgrastim) — a recombinant human granulocyte colony-stimulating factor (G-CSF).

Sandoz is seeking approval for the same indication as the reference product. Pegfilgrastim is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in patients with cancer (non-myeloid) who receive chemotherapy that can cause fever and a low blood cell count (febrile neutropenia). In the US, the incidence of febrile neutropenia is estimated to be more than 60,000 a year, accounting for nearly eight cases per 1,000 cancer patients.[1] Approximately 1.6 million people per year in the US develop non-myeloid cancer.[2]

“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, and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “If approved, physicians will have another high-quality Sandoz treatment option for patients needing granulocyte colony-stimulating factors” McCamish continued.

Sandoz believes that the totality of 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.

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