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Lee Schwartzberg, MD, FACP: Biosimilar Education for Oncologists
Lee Schwartzberg, MD, FACP, The West Clinic, explains the kinds of education that oncology providers still need to feel comfortable with biosimilars.
Transcript
I think biosimilar education is still needed to understand the regulatory difference between the originator product, which has to show in phase 3 trials that it's better or noninferior to another agent, and that it has efficacy and safety. The FDA approves initial drugs based on efficacy and safety. Biosimilars are approved with less clinical evidence because they're really mirroring the originator products, so it's highly technical in terms of the analytic variables that have to be satisfied for a biosimilar compared to an originator. As oncologists understand that process better, they'll become more comfortable with it.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
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.
Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry
December 20th 2023At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
