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Active Surveillance of Follow-On Biologics: A Prescription for Uptake

Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS - Drug Safety

  • Commentary & Opinion
| February 2017
  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

Active post-market surveillance of biosimilars using insurance claims databases is both feasible and necessary to address physician skepticism about biosimilar safety and effectiveness, which remains a major barrier to prescribing and cost savings.

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Daval CJR, Kesselheim AS - STAT

  • Commentary & Opinion
| October 2026
  • Regulation and Clinical Evidence
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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway

Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy

  • Research Publications
| October 2026
  • Price, Value, and Access
  • Regulation and Clinical Evidence
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Politics and the Patient Encounter, in Dire Times

Avorn J - MedPage Today

  • Commentary & Opinion
| October 2026
  • Regulation and Clinical Evidence
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