- April 13, 2022
April 13, 2022
1:00 p.m. to 3:30 p.m
About this Webinar:
The Food and Drug Administration (FDA) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) are announcing 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 will share their experience with biosimilars, their perspectives on how to improve the efficiency of biosimilar evaluations, and how to increase biosimilar adoption, including the role of clinical pharmacology. Enhanced knowledge and adoption of biosimilar products will help provide more affordable choices for patients.
The presentations will highlight the successes, challenges, and opportunities for the use of biosimilars in the clinic, informed by the available experience in multiple therapeutic areas (e.g., oncology, rheumatology, gastroenterology, endocrinology). Strategies to improve biosimilar adoption in the future will also be discussed, including the potential role of clinical pharmacology.
Meeting Information and Registration:
This workshop is open to the public; however, registration is required. Persons interested in attending this public workshop must register 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://www.pharmacy.umaryland.edu/centers/cersievents/biosimilars2022/.
If you have any additional questions about this workshop, please contact:
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002