On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.
The newest field of health care to experience biosimilar competition is the ophthalmology space, particularly the retinal disease treatment sector. Currently, the United States and the United Kingdom each have 2 ranibizumab biosimilars and the European Union only has 3, all of which were approved in the last 2 years. Additionally, more ranibizumab biosimilars referencing Lucentis and a slew of aflibercept biosimilars referencing Eylea are expected to enter the market over the next few years. Although all data shows these products to be bioequivalent to their reference products, the lack of real-world evidence around the world has left many ophthalmologists and biosimilar experts struggling to gain clarity on the safety of these products.
Furthermore, there is even more confusion about the meaning of interchangeability after 1 ranibizumab product (Cimerli) was granted an interchangeability designation by the FDA despite the label only applying to products dispensed through pharmacies and the label being granted without requiring data from a switching study.
Today, I’m joined by Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars, to discuss these issues and the FDA’s efforts to instill public confidence in ophthalmology biosimilars. Dr. Yim has worked extensively to help create the FDA’s education material on biosimilars and spread the FDA’s view that biosimilars are as safe and clinically effective as their reference products.
Prior to her work at the FDA, she was a clinical fellow at the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Disease and served as a medical officer for the US Army for over 10 years. She also hosted the FDA’s workshop on increasing efficiency within biosimilar development programs, presented at the DIA Biosimilars Conference, and was a featured panelist for our most recent LinkedIn Live event on ophthalmology biosimilars last fall.
To check out part 1 of this interview series (written Q&A with Samsung Bioepis’ Kyung-Ah Kim), click here.
Coming soon, part 3 will be a video interview about the initial market response to ophthalmology biosimilars and how industry leaders can work together to increase uptake.
To learn more about the approval of Cimerli, click here.
To learn more about ophthalmology biosimilars, click here.
To learn more about interchangeability, click here.
To learn more about clinical efficacy testing, click here.
To check out the FDA’s overview page on biosimilars, click here.
To check out the FDA’s patient-focused biosimilar education materials (English and Spanish versions), click here.
To check out the FDA’s biosimilar education materials for health care professionals, click here.
For more information on the FDA's biosimilar curriculum, click here.
For more information on the FDA's free CE courses on biosimilars, click here and use the filter function to select biosimilars.