- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Dr Bruce A. Feinberg: Biosimilar Labeling and Extrapolation
Bruce A. Feinberg, DO, CMO, Cardinal Health Specialty Solutions, discusses biosimilar labeling and concerns with extrapolation.
Transcript:
What are some considerations in the labeling of biosimilars?
The biggest consideration in biosimilar labeling is the fact of extrapolation. Extrapolation relates to the fact that a biosimilar that may have a half-dozen specific disease indications, will likely only be clinically tested in 1 of those indications. If it is proven to be equivalent by all the different measures the FDA is using, then the FDA appears to be granting, by extrapolation, the expanded label to all indications. So, there is a big difference from a branded drug, which had to have clinical trials in each of the 6, to a biosimilar which is only going to have a clinical trial done in 1 of the 6.
The Next Frontier: Oncology Biosimilars in 2025 and Beyond
January 13th 2025The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
