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.
- 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
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.
- How Does Biosimilar Availability Create Value for the Patient? A Conversation About Avenues to Widen Access to Biologics
- Biosimilars' Key Next Steps: What Will the Future Bring?
- Biosimilars: Market Access Challenges & Opportunities Worldwide
- Biosimilars: Unleashing The Potential For Improved Patient Access And Cost Savings In The United States
Manuscripts & Reports
- Moorkens E, Lacosta T B, Dawoud D, et al. A Systematic Literature Review of Gaps and Challenges in Value Assessment of Biosimilars: An ISPOR Special Interest Group Report. Value in Health 2023;26(8):1137-1144.
- Opening Up a Discussion on Biosimilar Value Assessment
- Biosimilar Terms and Definitions Monographs
- 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?
Liese Barbier, MSc, PharmD, PhD
Catarina Lopes Pereira, MSc, PharmD
These activities allow for a variety of members to participate and also facilitates disseminating content in Webinars, Journal Clubs, Conference Sessions, etc.
Gaps and Challenges in Value Assessment of Biosimilars
Steven Simoens, MSc, PhD, BA, MA
Questions or ideas? Please send an email.