Sandoz Announces New Phase I Data On Proposed Biosimilar Pegfilgrastim


(RTTNews.com) - Sandoz, a division of Novartis ( NVS ), announced data demonstrating the pharmacokinetics or PK, pharmacodynamics or PD, safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta.

The Phase I 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 for use in the same indication as the reference biologic. Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor [G-CSF]).

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