The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics licence 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).
Novartis company Sandoz is currently seeking approval for the same indication as the reference product, pegfilgrastim, a prescription medicine.
Pegfilgrastim is used to help reduce the chance of infection due to 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, occurrences of febrile neutropenia are estimated to be more than 60,000 per annum, accounting for nearly eight cases per 1,000 cancer patients. An estimated 1.6 million Americans develop non-myeloid cancer every year.
Sandoz global biopharmaceutical and oncology injectables development head Mark McCamish said: “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.
“If approved, physicians will have another high-quality Sandoz treatment option for patients needing granulocyte colony-stimulating factors.”
The BLA is based on data from three pivotal clinical trials, which include a pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients.
The company believes that the totality of evidence in its submission will show that the proposed biosimilar is highly similar to the reference product, which will justifies use of biosimilar pegfilgrastim in the reference product’s indication.
Currently, Sandoz markets three biosimilars. In September, the company launched the first biosimilar in the US and recently had its regulatory submission for proposed biosimilar etanercept accepted by the FDA.
The proposed biosimilar pegfilgrastim filing is the second of ten regulatory filings planned by the company over the next three years.
