A large multicenter, randomized, double-blind, crossover study in healthy volunteers, comparing pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar pegfilgrastim with European and United States reference pegfilgrastim.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2019.37.15_suppl.e23118
Abstract: e23118 Background: Similarity of the pharmacokinetic (PK)/pharmacodynamic (PD) profiles of Sandoz proposed biosimilar pegfilgrastim and EU-reference biologic was confirmed in a pivotal Phase I study. In order to confirm PK/PD similarity to the US reference… read more here.
Keywords: randomized double; reference; similarity; study ... See more keywords
Physicochemical and functional characterization of MYL-1501D, a proposed biosimilar to insulin glargine
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DOI: 10.1371/journal.pone.0253168
Abstract: Insulin glargine is a long-acting analogue of human insulin that has been used to manage hyperglycemia in patients with diabetes mellitus (DM) for nearly 20 years. Insulin glargine has a relatively constant concentration-time profile that… read more here.
Keywords: biosimilar insulin; insulin glargine; proposed biosimilar; myl 1501d ... See more keywords
Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies.
Sign Up to like & getrecommendations! Published in 2019 at "Future oncology"
DOI: 10.2217/fon-2018-0878
Abstract: Aim: This analysis compares safety data for Sandoz proposed biosimilar (LA-EP2006) and reference pegfilgrastim from a Phase I pharmacokinetic/pharmacodynamic study in healthy volunteers (HVs) and two Phase III confirmatory studies in patients with breast cancer… read more here.
Keywords: phase; analysis; safety; proposed biosimilar ... See more keywords