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.
Presentations
- ISPOR 2023: What Is the Value of Real-World Evidence for Biosimilars?
- ISPOR Europe 2022: Current Approaches for Biosimilars Value Assessment and Reimbursement Decision Making: Mapping Health Technology Assessment (HTA) Practices Internationally
- ISPOR 2022: The Evolution of Biosimilar Markets: Key Elements for Long-Term Sustainability of the Healthcare Ecosystem
- ISPOR Europe 2021: Biosimilars Tendering in Europe: Key Learnings Towards Sustainable Practices
- Virtual ISPOR 2021: Value Assessment of Biosimilars: Challenges and Considerations
- ISPOR Europe 2020: Drug Shortages During the COVID-19 Pandemic: Is there a Role for Accelerated Approval and Uptake of Biosimilars to Play?
- ISPOR Europe 2019: ISPOR Biosimilars Special Interest Group And ISPOR Central And Eastern Europe Consortium- Biosimilars- An Opportunity For Countries With Restricted Resources To Improve Patient Access?
- ISPOR 2019: Improving Patient Access to Life Saving Therapies: What Needs to Be Done to Fulfill the Promise of Biosimilars?
Leadership
Chair-Elect
Teresa Barcina
Chair
Liese Barbier, MSc
Past Chair
Catarina Lopes Pereira, MSc, PharmD
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
Aurelio Arias
Inês Oliveira
Key Project
Gaps and Challenges in Value Assessment of Biosimilars
Co-Chairs:
Teresa Barcina
Steven Simoens, MSc, PhD, BA, MA
Background and Objectives for Key Project
Questions or ideas? Please send an email.