Clinical Pharmacology Corner: FDA Announces Webinar on Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology

FDA Announces Webinar on Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology

FDA Announces Webinar on Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology On Wednesday April 13th, 2022, the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), Office of Clinical Pharmacology and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will hold a public webinar entitled "Biosimilars: A Decade of Experience and Future Directions—Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology." Comparative analytical studies are the foundation to demonstrating biosimilarity. Comparative clinical studies (e.g., clinical pharmacology and comparative clinical studies) are conducted after extensive comparative analytical assessments have been completed. These clinical studies aim to demonstrate that there are no clinically meaningful differences between the biosimilar and reference products, in contrast to demonstrating clinical benefits for the approval of an innovator biological product. Clinical pharmacology data, including pharmacokinetic and when feasible pharmacodynamic data, have the potential to streamline biosimilar development programs, as comparative clinical studies are generally more costly and lengthy. In this webinar, leading academic clinicians with specialties in several therapeutic areas (i.e., oncology, rheumatology, gastroenterology, endocrinology) will share their experience with biosimilars, highlighting successes and challenges, as well as their perspectives on how to improve the efficiency of biosimilar evaluation and adoption, including the role of clinical pharmacology. Enhanced knowledge and adoption of biosimilar products will help provide more affordable choices for patients. Date/Time of the Webinar: Date: Wednesday, April 13, 2022 Time: 1:00 to 3:30 p.m. This webinar is open to the public; however, registration is required at: https://www.eventbrite.com/e/biosimilars-a-decade-of-experience-and-future-directions-tickets-253436123267. More information about this event can be found at: https://go.usa.gov/xtGg7. The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs. We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov. This communication was prepared by the Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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