FDA Accepts New Biosimilar Application from Sandoz


Treatment helps reduce infection risk from low white blood cell count in cancer patients receiving chemotherapy.

Treatment helps reduce infection risk from low white blood cell count in cancer patients receiving chemotherapy.

Another biosimilar drug from Sandoz may soon help save consumers money on needed specialty medications.

The manufacturer announced Wednesday that the FDA accepted a new Biologics License Application via the 351 (k) pathway for a proposed biosimilar to pegfilgrastim (Neulasta) by Amgen.

The recombinant human granulocyte colony-stimulating factor (G-CSF) decreases the risk for infection from a low white blood cell count in patients with non-myeloid cancers undergoing chemotherapy that may lead to fever and febrile neutropenia.

Approval is sought for the biosimilar under the same indications as the reference product.

Febrile neutropenia affects more than 60,000 people per year in the United States, which accounts for approximately 8 cases per 1000 cancer patients. Non-myeloid cancer is reported in approximately 1.6 million people annually in the United States.

“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, MD, PhD, Sandoz head of Global Biopharmaceutical & Oncology Injectables Development. “If approved, physicians will have another high-quality Sandoz treatment option for patients needing granulocyte colony-stimulating factors.”

The biosimilar is currently being evaluated in 3 clinical trials, including a pharmacokinetic and pharmacodynamic study in healthy patients, and 2 comparative efficacy and safety studies in patients with breast cancer.

Sandoz had the first biosimilar launch in the United States earlier this year following the approval of Filgrastim-sndz (Zarxio), which is biosimilar to Amgen’s Neupogen (filgrastim). The biosimilar finally hit the market on September 3, 2015.

The FDA also recently accepted a regulatory submission for proposed biosimilar etanercept.

Express Scripts estimated earlier this year that approximately $250 billion could be saved over the next decade if 11 biosimilars were to be approved.

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