Mission

To identify and discuss emerging issues of biosimilars, as related to their originator biologics, focusing on health economics and outcomes research (HEOR) and reimbursement policy.  

Goal

  • Discuss the current state of biosimilars as a unique category of therapeutics
  • Highlight the gaps in understanding and evaluating biosimilars from an HEOR lens
  • Propose solutions to issues pertaining to biosimilar accessibility, adoption, utilization, value, and impact

Background

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.  They also contribute significantly to the overall drug expenditure in most healthcare systems, however. For example, the average daily cost of a biologic in the US is $45 when compared with a chemical drug that costs only $2. Thus, the financial burden of reimbursing patent protected biologics for all eligible patients may not be affordable, especially for low or middle-income countries.

The United States’ Food and Drug Administration (FDA) 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.


Leadership


Cate Lockhart, MS, PharmD, PhD

Executive Director, BBCIC
Asheville, NC, United States

Jacqueline Vanderpuye-Orgle, PhD

Vice President, Parexel
LA VERNE, CA, United States

Catarina Lopes Pereira, MSc, PharmD

Global Market Access Manager, Medac GmbH
Brussels, Belgium

Working Groups:


 

Member Engagement


These activities allow for a variety of members to participate and also facilitates disseminating content in Webinars, Journal Clubs, Conference Sessions, etc.

Co-Chairs:

  • Liese Barbier, MSc, PharmD, PhD Researcher, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium
  • Maja Sercic, MsPharm, Policy & Science Manager, Medicines for Europe, Belgium
  • Dalia Dawoud, MSc, PhD, BSc, Scientific Adviser, NICE, London, United Kingdom
  • Ines Oliveira, MS, Market Access and Health Economic Analyst, Integrated Strategic Market Access Services (ISMS), Netherlands

Key Project

Gaps and Challenges in Value Assessment of Biosimilars

Co-Chairs:

  • Steven Simoens, MSc, PhD, Professor, KU Leuven, Leuven, Belgium
  • Teresa Barcina Lacosta, PhD researcher, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium
  • Evelien Moorkens, PhD Researcher, KU Leuven, Leuven, Belgium 

Background and Objectives for Key Project

The aim of the key project is to develop a manuscript (to be submitted to Value in Health) that reports on a systematic literature review of the gaps and challenges of the health technology assessment of biosimilars. The manuscript will not only include a multi-stakeholder inventory and discussion of challenges, but will also propose methodological recommendations and practical guidance to address these.

Questions or ideas? Please send an email.

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