Sandoz announces results of PROTECT2 study of biosimilar pegfilgrastim with the reference product, Neulasta.
Sandoz has announced results from the PROTECT2 study which compared the safety and efficacy of proposed biosimilar pegfilgrastim with the reference product, Neulasta . The study met its primary endpoints - showing it to be both equivalent and non-inferior to the reference product. Data was presented at the American Society of Hematology (ASH), Orlando, Florida.
Additional data from the study showed that there were no clinically meaningful differences between the proposed biosimilar pegfilgrastim and the reference product. Adverse events were similar and consistent with the known safety profile of pegfilgrastim, and no neutralizing anti-pegfilgrastim antibodies were detected.
Comment: The patents on Neulasta expired in October 2015 in the US and will expire in August 2017 in the EU.
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