https://pmc.ncbi.nlm.nih.gov/articles/PMC5094503/
Confirmation of Biosimilarity in a Pharmacokinetic/Pharmacodynamic Study in Healthy Volunteers for...
A phase 1 pharmacokinetic (PK) and pharmacodynamic (PD) study was conducted to demonstrate similarity of a proposed pegfilgrastim biosimilar to its reference...
in ahealthy volunteersconfirmationbiosimilarity
https://deepai.org/publication/assessing-biosimilarity-using-functional-metrics
Assessing Biosimilarity using Functional Metrics | DeepAI
Feb 16, 2019 - 02/16/19 - In recent years there have been a lot of interest to test for similarity between biological drug products, commonly known as biolo...
assessingbiosimilarityusingfunctionalmetrics
https://www.sciencedaily.com/releases/2016/02/160205144512.htm
Assessing the biosimilarity of protein drugs: New study shows method's precision | ScienceDaily
First-ever interlaboratory study of four versions of a therapeutic protein drug -- all manufactured from living cells -- reports that an established analytical...
https://www.sgs.com/en-us/whitepapers/primary-and-higher-order-structural-characterization-strategy-for-biosimilarity-assessment-form
Primary and Higher-Order Structural Characterization Strategy for Biosimilarity Assessment | SGS USA
This article addresses some issues involved in meeting regulatory characterization expectations for biosimilars.
https://github.com/BioSysLab/Biosimilarity
GitHub - BioSysLab/Biosimilarity: Aggregation of biological similarities at different levels from...
Aggregation of biological similarities at different levels from GEx data. - BioSysLab/Biosimilarity
githubbiosimilarityaggregation