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Updated: Dec 18, 2025
Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
Published on: May 1, 2019
The New Drug Lag: EU Lags in Review Times of Monoclonal Antibodies
Vibha Sharma1, Vivek Dasharath Deore1, Sandhya Vivek Deore1
1Department of Health Sciences, College of Health and Human Services, Eastern Michigan University, Marshall Building, Ypsilanti, MI, 48197, USA.
Background:
FDA had been criticized for its slow review of new drugs. Critics complained of a "drug lag" from which US patients suffered when compared to Europeans. Since the advent of PDUFA, however, the FDA has demonstrated a possible slight advantage in review time when compared to the EMA.
Methods:
Submission and approval dates for monoclonal antibodies were collected from the FDA and EMA websites.
Results:
When using monoclonal antibodies as examples of complex, yet important new therapeutic agents, it was determined that the FDA reviews these agents on average 5 months faster than the EMA.
Conclusion:
The review processes within each agency may have reached their highest efficiencies without making further changes in a review system.
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