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Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities
Author(s) -
Bulatao Ilynn,
Pinnow Ellen,
Day Brendan,
Cherkaoui Sanae,
Kalaria Manish,
Brajovic Sonja,
Dal Pan Gerald
Publication year - 2020
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1948
Subject(s) - postmarketing surveillance , safety profile , medicine , business , pharmacology , adverse effect
We examined the relationship of regulatory and review characteristics to postmarketing safety‐related regulatory actions for 61 new therapeutic biologics (NTBs) approved between October 1, 2002 and December 31, 2014. We also compared NTBs with small‐molecule new molecular entities (NMEs) on these measures. Postmarketing safety‐related regulatory actions were defined as a safety‐related withdrawal or a safety‐related update to a safety section of the label through June 30, 2018. Four NTBs were withdrawn, two for safety reasons. At least one safety‐related update was added to the labels of 54 (88.5%) NTBs. Label updates occurred throughout the follow‐up period. Time to the first safety‐related regulatory action was shorter for NTBs approved under accelerated approval. The occurrence of safety events was more likely to occur with NTBs than with NMEs. This may be explained in part by the higher proportion of NTBs in the anatomical therapeutic chemical classification categories with higher frequency of safety‐related updates. NTBs also had shorter time to safety events than NMEs. These findings underscore the importance of continued development of the life cycle safety surveillance system for both drugs and biologics with consideration for product type and its characteristics, including pharmacologic action.