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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.
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.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
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.
Duke Publishes Recommendations for Developing CGT Biosimilars
October 9th 2024Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.
