Organon commissioned an independent analysis in partnership with Charles River Associates to work with a group of national and international biosimilar experts to identify the optimal, sustainable biosimilar policies and to develop actionable policy recommendations to improve biosimilar sustainability for a wide set of countries.

What is a Biosimilar?

A biosimilar is a biologic medicine that has been developed to be highly similar to an already approved biologic, or reference biologic. Biologics are complex in structure and generally expensive to manufacture. A biosimilar must go through a rigorous approval process to demonstrate there are no clinically meaningful differences in safety, purity or potency, compared to the reference biologic.


Report Methodology

A literature review was undertaken to develop a 'sustainability scorecard' of 10 elements that characterise a sustainable environment for biosimilars. Country policy landscape assessments were then conducted, and followed by two international advisory boards to inform the development of actionable policy recommendations.

  • Sustainability Scorecard

  • Market Assessments

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  • Policy Recommendation Development


CRA Literature Review

Expert Validation

Sustainability is seen as a significant issue for biosimilars due to:

  • Variation in biosimilar uptake
  • Country confidence
  • Uncertainty regarding biosimilar practices and policy
  • Conflation of the application of policy issues to biosimilars and generic small molecules

Biosimilar Policy Sustainability Elements

These elements were selected as an objective rating system to evaluate the level of sustainability of biosimilar policy environment in
each market.

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  • Ensure safe and high-quality medicines

  • Facilitate cost savings for healthcare providers

  • Ensure healthy levels of supply

  • Maintain incentives for continued biologic research & innovation

  • Mitigate against biosimilar misconceptions

  • Facilitate efficient & streamlined patient access

  • Encourage multi-stakeholder decision-making

  • Facilitate sustainable levels of biosimilar competition

  • Increase prescribing options for patients & healthcare professionals

  • Maintain predictable market functioning


See How Sustainable Biosimilar Policies Stack Up Worldwide

Choose one policy to compare up to 3 countries at a time. Clear selections with the reset button below.

Select the Policy:

  • Please Select
  • Manufacturing and R&D
  • Regulatory Approval
  • Health Technology Assessment
  • Pricing and Reimbursement
  • Contracting
  • Biosimilar Education and Understanding
  • Prescribing
  • Dispensing
  • Monitoring

Select up to Three Countries:

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Please select a Policy and Country to see the result.

Learn More about Biosimilar Policies Around the World

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This paper seeks to address three key questions:

  • Can we define an ‘ideal’ biosimilar policy toolkit that will ensure long term sustainability that is applicable across different market circumstances, across different types of biosimilars?
  • To what extent does existing biosimilar policy across a global selection of countries promote a long term sustainable environment benefitting all stakeholders?
  • Can we provide countries with tangible and actionable recommendations for meaningful improvements to the biosimilar sector applicable to different types of biosimilars?