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Phase III Data Shows Sandoz Proposed Biosimilar Pegfilgrastim Has Similar Safety and Efficacy as the Reference Product
NASDAQ (12/17/15)
Data from a Phase III study by Novartis International show that the proposed biosimilar pegfilgrastim from by Sandoz has safety and efficacy that are similar to the reference product, Neulasta. The PROTECT 2 study compared the proposed biosimilar with the reference product for the prevention of neutropenia in patients with breast cancer. The results demonstrated equivalence and non-inferiority to the reference product. Researchers found no clinically meaningful differences between the biosimilar and the reference drug. The findings were presented at the 57th American Society of Hematology Annual Meeting and Exposition in Orlando.
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