Trials & Filings

Sandoz Phase I Biosimilar Achieves Positive Results

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

Author Image

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...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters