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Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review.

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Biosimilar market sustainability faces challenges threatening drug availability and innovation. This study identifies key dimensions and stakeholder considerations for ensuring the long-term viability of biosimilar markets.

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Area of Science:

  • Pharmacoeconomics
  • Health policy
  • Pharmaceutical market analysis

Background:

  • Biosimilars offer alternatives to reference biologics, but market sustainability is threatened by various challenges.
  • Lack of systematic frameworks hinders evaluation and action to address these threats.
  • Consequences include potential drug shortages, reduced competition, and diminished innovation.

Purpose of the Study:

  • To establish key dimensions of biosimilar market sustainability through a literature review.
  • To identify critical stakeholder groups and prevalent sustainability factors.
  • To develop a framework for ensuring the long-term viability of the biosimilar market.

Main Methods:

  • A contemporary, targeted review of global biosimilar literature.
  • Identification and analysis of commonly referenced stakeholder groups.
  • Analysis of prevalent sustainability dimensions discussed in the literature.

Main Results:

  • Key stakeholder groups include payers, regulatory authorities, providers, manufacturers, patients, and purchasers.
  • Prevalent sustainability dimensions encompass pricing, cost-savings, regulatory barriers, manufacturer processes, provider choice, knowledge, and procurement.
  • These findings were synthesized into a framework for biosimilar market sustainability.

Conclusions:

  • A comprehensive framework considering multiple stakeholder perspectives is crucial for biosimilar market sustainability.
  • Addressing pricing, regulatory, and access barriers is essential for long-term viability.
  • This framework aids stakeholders in ensuring the continued availability and innovation of biosimilars.