Biosimilars and Real-World Evidence: A Path to Regulatory Efficiency and Adoption
Dec. 9, 2021 • Webinar 2 pm ETRegister
Biosimilars—a fast-growing class of products that are highly similar to and have no clinically meaningful differences from existing FDA-approved branded biologics—are poised to bring high-quality, lower cost treatment options to key therapeutic areas including oncology, rheumatology, ophthalmology, diabetes and others. However, barriers to adoption, including provider/patient comfort, still exist in the US, which can contribute to limitations in realizing the full potential of biosimilars.
Real-world evidence (RWE) can provide critical insights into biosimilar utilization and outcomes beyond clinical trials, and address some of these lingering clinical barriers to adoption. Furthermore, RWE may have a potential role in advancing the development of biosimilars and meeting regulatory standards necessary for interchangeability designation. Join experts from Cardinal Health Specialty Solutions to explore the critical dynamics and need for real-world evidence and biosimilars in the US, including:
- U.S. market dynamics for biosimilars
- Considerations for RWE generation and application to biosimilars
- The role of RWE in supporting biosimilar regulatory efficiencies and future market viability