Analytical Test Series Would Allow Characterization Of Follow-On Biologics – GPhA
This article was originally published in The Pink Sheet Daily
Executive Summary
"No 'one' analytical method is currently capable of such comprehensive analysis," a Generic Pharmaceutical Association white paper states. Previously reported characterization problems were due to inappropriate or misinterpreted tests, GPhA maintains.
You may also be interested in...
BIO Opposes Terms "Comparability" & "Therapeutic Equivalence" For Follow-On Biologics
The industry organization continues to emphasize the need for full clinical testing for follow-on biologics. BIO acknowledges that an abbreviated regulatory process may be possible in the future for certain follow-on products.
BIO Opposes Terms "Comparability" & "Therapeutic Equivalence" For Follow-On Biologics
The industry organization continues to emphasize the need for full clinical testing for follow-on biologics. BIO acknowledges that an abbreviated regulatory process may be possible in the future for certain follow-on products.
J&J Hopes Eprex Experience Will Influence Follow-On Biologics Regulatory Pathway
Johnson & Johnson is discussing its Eprex manufacturing complications in Europe with regulators working to develop a follow-on biologics pathway