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Sandoz Phase I Biosimilar Achieves Positive Results

Proposed biosimilar to Neulasta demonstrates PK, PD, safety and efficacy

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By: Kristin Brooks

Managing Editor, Contract Pharma

Sandoz, a division of Novartis, achieved positive results from a Phase I study demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta, which is used to treat chemotherapy induced neutropenia. The study, conducted in healthy volunteers, confirmed that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of PK, PD, safety and immunogenicity profiles.
 
Sandoz biosimilar pegfilgrastim is currently under review by the European Medicines Agency (EMA) for use in the same indication as the reference biologic. Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor [G-CSF]).
 
“At Sandoz, we are committed to developing high-quality biosimilar and generic medicines that provide the oncology community with treatment options to help manage their patients,” said Mark Levick, MD Ph.D., global head of development, Biopharmaceuticals, Sandoz, “And it starts with following the science. These findings add to the totality of evidence supporting our proposed biosimilar pegfilgrastim.”

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