Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities
- 1 December 2020
- journal article
- research article
- Published by Wiley in Cancer Cell
- Vol. 108 (6), 1243-1253
- https://doi.org/10.1002/cpt.1948
Abstract
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 Four NTBs were withdrawn, two for safety reasons.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.Keywords
Funding Information
- U.S. Food and Drug Administration
This publication has 13 references indexed in Scilit:
- A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and BiologicsJAMA Oncology, 2018
- Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014Cancer Cell, 2017
- Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort studyBMJ, 2017
- Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010JAMA, 2017
- Adverse Reactions to Biologic TherapyImmunology and Allergy Clinics of North America, 2017
- Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market WithdrawalsHealth Affairs, 2014
- Post-Approval Safety Issues with Innovative Drugs: A European Cohort StudyDrug Safety, 2013
- Additional safety risk to exceptionally approved drugs in Europe?British Journal of Clinical Pharmacology, 2011
- Drug-Review Deadlines and Safety ProblemsNew England Journal of Medicine, 2008
- Industry funding of the FDA: effects of PDUFA on approval times and withdrawal ratesNature Reviews Drug Discovery, 2005