Using medicare administrative data to conduct postmarketing surveillance of follow-on biologics: Issues and opportunities

Lisa D. DiMartino, Lesley H. Curtis, Roger L. Williams, Darrell R. Abernethy, Kevin A. Schulman

Research output: Contribution to journalArticle

Abstract

By 2010, it is estimated that $10 billion in biologics will have lost patent protection and that generic versions, or "follow-on" biologics, will begin to emerge. The manufacturing processes required to produce biologics are complex, and safety and efficacy profiles may be specific to the manufacturer. Postmarketing surveillance studies may be required to detect rare safety signals. Medicare claims may provide a useful mechanism for postmarketing surveillance of follow-on biologics. The authors briefly describe the regulation of innovator and follow-on biologics, the need for postmarketing surveillance of follow-on biologics, and how Medicare claims data might be used to monitor postapproval safety.

Original languageEnglish (US)
JournalFood and Drug Law Journal
Volume63
Issue number4
StatePublished - 2008
Externally publishedYes

Fingerprint

Medicare
Biological Products
surveillance
patent protection
innovator
Safety
manufacturing
regulation

ASJC Scopus subject areas

  • Law
  • Public Health, Environmental and Occupational Health
  • Pharmacology

Cite this

DiMartino, L. D., Curtis, L. H., Williams, R. L., Abernethy, D. R., & Schulman, K. A. (2008). Using medicare administrative data to conduct postmarketing surveillance of follow-on biologics: Issues and opportunities. Food and Drug Law Journal, 63(4).

Using medicare administrative data to conduct postmarketing surveillance of follow-on biologics : Issues and opportunities. / DiMartino, Lisa D.; Curtis, Lesley H.; Williams, Roger L.; Abernethy, Darrell R.; Schulman, Kevin A.

In: Food and Drug Law Journal, Vol. 63, No. 4, 2008.

Research output: Contribution to journalArticle

DiMartino, Lisa D. ; Curtis, Lesley H. ; Williams, Roger L. ; Abernethy, Darrell R. ; Schulman, Kevin A. / Using medicare administrative data to conduct postmarketing surveillance of follow-on biologics : Issues and opportunities. In: Food and Drug Law Journal. 2008 ; Vol. 63, No. 4.
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