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IOM Review of FDA--approved biologics labeled or studied for pediatric use
Marilyn J Field1, Lara K Ellinger, Thomas F Boat
1Senior Program Officer, Institute of Medicine, 500 Fifth St NW, Washington, DC 20001, USA. mfield@nas.edu
Insights
Most biologics approved between 1997-2010 include pediatric information in labeling, with most having registered pediatric trials. This trend indicates improved pediatric drug safety data for biologics.
Area of Science:
- Pharmacology and Therapeutics
- Pediatric Drug Development
- Regulatory Science
Background:
- Public policies have aimed to increase pediatric drug information, but pediatric labeling for biologics remains under-examined.
- This study investigates pediatric labeling and study data for biologics, excluding vaccines.
Purpose of the Study:
- To assess the extent of pediatric use information and studies for biologics approved between 1997 and 2010.
- To analyze pediatric labeling and clinical trial registration for these biologics.
Main Methods:
- Reviewed labeling for 96 non-vaccine biologics licensed 1997-2010 and marketed in 2010.
- Searched ClinicalTrials.gov for registered pediatric studies.
- Examined labeling and studies for 55 vaccines separately.
Main Results:
- ~60% of biologics showed approved pediatric use or study information.
- ~85% had at least one registered pediatric trial.
- ~90% of biologics and 95% of vaccines had some form of pediatric information or study data.
Conclusions:
- A majority of biologics approved in the last 15 years contain pediatric information in labeling.
- Pediatric trials are registered for a substantial majority of these biologics, enhancing pediatric safety data.
Background:
Studies have examined the extent to which public policies such as the Best Pharmaceuticals for Children Act have increased pediatric information in drug labeling. Little attention has focused on pediatric labeling of biologics. This analysis examines the extent to which biologics are labeled for pediatric use or have been studied in children.
Methods:
The analysis covers the 96 biologics (excluding vaccines) that were first licensed by the Food and Drug Administration between 1997 and 2010 and were still marketed as of 2010. Product labeling was consulted for information on approved pediatric uses, pediatric studies, or pediatric safety warnings based on analyses of adverse events. The online database ClinicalTrials.gov was searched for registered pediatric studies of these biologics. A separate analysis examined labeling and studies for 55 vaccines.
Results:
For ∼60% of the 96 biologics, labeling shows approved pediatric use or pediatric study information or both. Approximately 85% of the biologics have ≥1 registered pediatric trial completed, underway, or planned. Overall, ∼90% are labeled for pediatric use, have pediatric information in the label, have a registered pediatric study, or have some combination of these characteristics. For the 55 analyzed vaccines, the corresponding figure is 95%.
Conclusions:
A majority of biologics approved in the past 15 years include some pediatric information in their labeling, and pediatric trials have been registered for a substantial majority of these products.
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