Posted by Michael Wonder on 27 Oct 2017
Sandoz proposed biosimilar pegfilgrastim accepted by EMA for regulatory review
27 October 2017 - Comprehensive data package demonstrates that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of safety, efficacy and quality.
Sandoz, a Novartis Division, and the global leader in biosimilars, announced today that its biosimilar to EU-authorised Neulasta (pegfilgrastim) has been accepted by the EMA for regulatory review.
The comprehensive data package, submitted as part of the marketing authorisation application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.
The clinical development program for Sandoz biosimilar pegfilgrastim includes data from Phase I pharmacokinetic and pharmacodynamic studies in healthy volunteers, as well as Phase III confirmatory safety and efficacy studies in breast cancer patients.
