Host Dr. John Sweetenham, associate director of Clinical Affairs at the UT Southwestern Harold C. Simmons Comprehensive Cancer Center, and Dr. Zeina Nahleh, breast cancer medical oncologist and regional chair of the Cleveland Clinic Florida Cancer Institute, discuss the new ASCO Expert Panel report on the use of biosimilars in oncology, and their potential as an affordable, effective alternative for cancer care.   Transcript Dr. John Sweetenham: Hello, I'm John Sweetenham the associate director for clinical affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center and host of the ASCO Daily News podcast. Today, we'll be discussing the use of biosimilars in oncology. These are licensed biological products that are largely analogous to the U.S. Food and Drug Administration (FDA)-approved originator or reference products, and a recent report from an ASCO Expert Panel found that biosimilars may be an affordable and effective alternative to their reference of biological product for cancer care.   Dr. Zeina Nahleh, was the co-chair of the Expert Panel that clarified the potential value and utility of biosimilars in oncology. I'm delighted to welcome her to the podcast today. Dr. Nahleh is a breast cancer medical oncologist who serves as the regional chair of the Cleveland Clinic Florida Cancer Institute.   My guest and I have no conflicts relating to our topic today. Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found in our transcripts at asco.org/podcasts. Dr. Nahleh, many thanks for being on the podcast today.   Dr. Zeina Nahleh: It's a great pleasure to be here.   Dr. John Sweetenham: Dr. Nahleh, oncology-related biosimilars were first approved by the FDA back in 2015. Could you open up by maybe giving us an explanation of exactly what biosimilars are and how these agents are currently being used specifically in oncology?   Dr. Zeina Nahleh: Biosimilars for oncology were developed for 2 purposes, basically: to hopefully decrease the overall costs of care, [and] to improve access to cancer therapies. The FDA has a clear definition of a biosimilar. It is a similar, but not identical to an already licensed biologic product. That's really the definition – it's similar in terms of quality, safety, and efficacy.   Now, biosimilars are produced in living cells. They are purified. They go through multi-step processes, so they're not really identical to the original product, but they're very similar. The use of biosimilars, as you mentioned, it started in 2015 as an unauthorized oncology product, and the FDA has since approved several biosimilar products. And the process to authorize this product goes through a lot of rigorous processes really of checks and balances, but they are really supposed to be equivalent in terms of safety and efficacy and not meaningfully different from the original reference product.   Dr. John Sweetenham: Thank you. One thing I should have mentioned right up front and apologize for not doing so is that I would certainly recommend that all our listeners take a look at the report that you co-authored with the other members of the panel because I think number 1, it's extremely informative in many domains, but I think it really gives an excellent description of the development process [of] biosimilars and [the] approval process, which is currently I think, relatively poorly understood.   On that theme, I think as a member of the panel, your panel report noted that there was a lack of clinician understanding about biosimilars and their utility. I think that's been reflected in the fact that the uptake of biosimilars in the oncology committee has been relatively slow. I think you probably agree with that. What do you think are the major barriers to biosimilar use that you found as you reviewed the literature? When do you think they are an acceptable alternative to the available reference biologics?   Dr. Zeina Nahleh: There are some barriers