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Postmarket policy considerations for biosimilar oncology drugs

Matthew J Renwick1, Kate Smolina1, Emilie J Gladstone1

  • 1School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, BC Canada.

The Lancet. Oncology
|January 14, 2016
PubMed

Insights

Biosimilar oncology drugs face varied market uptake due to differing national policies. Understanding these postmarket strategies is crucial for improving biosimilar accessibility and affordability in cancer care.

Area of Science:

  • Health Economics
  • Oncology
  • Pharmaceutical Policy

Background:

  • Oncology biological products represent a significant financial burden on patients and healthcare systems.
  • Patent expirations for major cancer biologics are enabling the market entry of biosimilars.
  • International harmonization of clinical and regulatory pathways for biosimilars is progressing, particularly in Europe and the USA.

Purpose of the Study:

  • To analyze international variations in pricing and market uptake of approved biosimilar oncology drugs.
  • To investigate the impact of national postmarket policies on disparities in biosimilar pricing and uptake.
  • To compare policy approaches to competition between biosimilars and originator biologics in selected countries.

Main Methods:

  • Policy review of seven European countries (Belgium, France, Germany, Italy, Netherlands, Norway, UK) and the USA.
  • Analysis of postmarket policies related to interchangeability, prescribing, dispensing, financing, tendering, and pricing.
  • Selection of countries based on diverse postmarket policy landscapes.

Main Results:

  • Substantial international variation exists in the pricing and market uptake of biosimilar oncology drugs.
  • Differences in national postmarket policies are likely contributors to these observed disparities.
  • The study examines specific policy areas including interchangeability, physician prescribing, pharmacist dispensing, hospital financing, tendering, and pricing.

Conclusions:

  • National postmarket policies significantly influence the pricing and market penetration of biosimilar oncology drugs.
  • Tailored policy interventions are needed to address international variations and optimize biosimilar utilization.
  • Further research into specific policy mechanisms can guide strategies for enhancing biosimilar accessibility and reducing healthcare costs.

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