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FDA accepts Sandoz’s filing for biosimilar to Amgen’s Neulasta cancer drug

The US Food and Drug Administration (FDA) has accepted Sandoz's biologics license application submission for its proposed biosimilar to Amgen's Neulasta (pegfilgrastim) cancer drug.

Novartis unit Sandoz is seeking approval for the similar indication as the reference product.

The company said the totality of evidence in its submission, including three clinical trails, will demonstrate that the proposed biosimilar is same to the reference product.

Pegfilgrastim is used to help reduce the risk of infection because of a low white blood cell count in patients with non-myeloid cancer who receive chemotherapy, which can result in fever and a low blood cell count (febrile neutropenia).

Sandoz head of global biopharmaceutical & oncology injectables development 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."

In September, Sandoz launched the first biosimilar, Zarxio (filgrastim-sndz), in the US. It is a copycat version of Amgen’s Neupogen cancer drug.

The FDA is currently reviewing the company’s biosimilar of Amgen’s Enbrel drug.

Sandoz has a pipeline with various biosimilars across several stages of development including five programs in Phase III clinical trials or registration preparation.