Global Multistakeholder Panel Provides First-of-its-Kind Guidance on Assessing the Value of Biosimilar Drugs

Published Aug 15, 2023

A Report of the ISPOR Biosimilar Special Interest Group

Lawrenceville, NJ, USA—August 15, 2023—Value in Health, the official journal of ISPOR—The Professional Society for Health Economics and Outcomes Research, announced the publication of a new ISPOR Report authored by the ISPOR Biosimilar Special Interest Group that provides an overview of gaps and challenges in the value assessment of biosimilars and identifying potential approaches to address them. The report, “A Systematic Literature Review of Gaps and Challenges in Value Assessment of Biosimilars – A Report of the ISPOR Biosimilar Special Interest Group,” was published in the August 2023 issue of Value in Health.

A biosimilar or biosimilar medicine is an FDA approved biological therapeutic product that is highly similar to an already FDA approved biological medicine. It is comparable in quality, safety, and efficacy as the approved reference drug. Biosimilars are typically lower cost alternatives to reference biologics, making these medications easier for patients to access.

In the United States, insurance companies pay pharmacy benefit managers (PBMs) to manage drug costs, which includes selecting medicines for insurance formularies, including biosimilar medicines. Outside the United States, many countries—from Canada, the United Kingdom, and Germany to countries in Asia, Australia, and South America—use health technology assessment (HTA) agencies to evaluate the value for a medicine, procedure or device covering both their direct and indirect consequences. The overall value may vary depending on the perspective taken, the stakeholders involved, and the decision context.

“Worldwide, few HTA agencies have produced a position statement on how to assess the value of a biosimilar or have provided detailed guidance under which circumstances which technique of economic evaluation applies to biosimilars, stated senior author Professor Steven Simoens, PhD, MSc, a health economist in the Department of Pharmaceutical and Pharmacological Sciences at KU Leuven in Leuven, Belgium. “As a result, value assessment practices of HTA agencies for biosimilars have varied between jurisdictions.”

Co-author, Dalia Dawoud, MSc, PhD, Associate Director (Research), Science, Policy and Research Programme at the National Institute for Health and Care Excellence (NICE), one of the United Kingdom’s HTA agencies and a director on ISPOR’s Board of Directors, agreed saying that, “There is ongoing debate about the methodology of value assessment for biosimilars. This report identifies the issues and proposes approaches to address the multiple challenges in biosimilar value assessment. It was important for an international, multistakeholder group from an objective scientific and educational organization to undertake this task. This consensus-developed report is an important step towards streamlining biosimilar value assessment. This will make biosimilars more readily available for patients, and the agencies’ assessment work easier.”

The resultant consensus-based report was developed from a systematic review of the relevant literature on the topic, internal meetings, input received during ISPOR conference presentations and finally, on 2 rounds of written peer review by members of the ISPOR Biosimilar Special Interest Group.

Highlights of the methods to address challenges in biosimilar value assessment:

  • Conduct a price comparison when biosimilar reimbursement is requested for the same indication as the reference biologic.
  • Conduct a full economic evaluation in other specific circumstances. For instance:
    • When the reference biologic is not reimbursed or is not the standard of care
    • When the biosimilar and reference biologic have different administration forms
    • When the biosimilar and reference biologic use different administration devices
  • The report also describes and provides approaches to several specific challenges:
    • Extrapolation of indication
    • Assessment in biologic-naïve and in biologic-experienced patients
    • Nocebo effect
    • Managed entry agreements
    • Value-added services
    • Health gains at population level

“Shedding light on the methodology of economic evaluation for biosimilars may serve to inform future biosimilar value assessments,” noted concluded lead author, Evelien Moorkens, PhD, MSc, market access specialist. “Improved methods used in the value assessment of biosimilars may contribute to reduced uncertainty from decision makers’ perspectives and better access to these therapies.”


ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2021 impact factor score is 5.156 and its 5-year impact factor score is 6.779. Value in Health is ranked 9th of 88 journals in health policy and services, 18th of 109 journals in healthcare sciences and services, and 50th of 381 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.
Website  | Twitter (@isporjournals)

Biologic drugs, also defined as large molecules (proteins, nucleic acids, and sugars that undergo production through complex and lengthy biotechnological processes), have established themselves as critical therapies that have changed the course of disease for many life-threatening conditions and those impacting patients’ quality of life. Examples include chronic diseases such as inflammatory bowel disease, rheumatoid arthritis, and various forms of cancer.

Biosimilars in general gain marketing authorization on the basis of scientific evidence that a biosimilar is similar to its reference biologic and that any differences are clinically not significant. For example, the US Food and Drug Administration has defined a biosimilar as “a biologic product that is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biologic product and the innovator product in terms of safety, purity and efficacy.”

Biosimilars offer an opportunity for improving access to high-priced biologic therapies, particularly for patient groups that had limited availability of the originator biologic due to cost constraints. Despite the availability of biosimilars, challenges in their value assessment and barriers in policy and clinical decision making may limit their widespread use. For more information and a number of educational resources on biosimilars, please visit the ISPOR Biosimilars Special Interest Group.

ISPOR members initiate ISPOR Special Interest Groups within a topic area to advance health economic and outcomes research and the use of this research in healthcare decisions. Special interest group members develop scientific and educational work products, such as conference and webinar presentations and publications.  ISPOR has 15 special interest groups. They include a range of topics from real world evidence to clinical outcome assessment to statistical methods in HEOR and digital health.

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