Event
M-CERSI Webinar: Biosimilars
Wednesday, April 13, 2022
1:00 p.m.-3:30 p.m.
Virtual
M-CERSI UMD
cersi@umd.edu
https://www.pharmacy.umaryland.edu/centers/cersievents/biosimilars2022/
Join us for the webinar “Biosimilars: A Decade of Experience and Future Directions—Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology” which will be held via Webex on Wednesday, April 13, 2022 from 1–3:30 p.m. ET. The webinar is free and sponsored by the Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), a collaboration between the University of Maryland, Baltimore and the University of Maryland, College Park. This webinar will be hosted jointly with the Office of Clinical Pharmacology in the U.S. Food and Drug Administration (FDA).
The presentations will highlight the successes, challenges, and opportunities for 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.
Register online to obtain login details
The agenda and participant biographies will be added closer to the event.
Background information:
The Biologics Price Competition and Innovation Act (BPCIA) of 2009 amended the Public Health Service Act and created an abbreviated approval pathway for biosimilars – biologic medicines that are demonstrated to be highly similar and have no clinically meaningful difference to FDA-approved reference products.[1] As of December 2021, FDA has approved 33 biosimilar/interchangeable products to 11 different reference products. Despite this progress, there are still barriers to biosimilar adoption. The FDA’s Biosimilar Action Plan of 2018 articulated the vision of ensuring access to safe and effective treatment options and identified four key focus areas, including improving the efficiency of biosimilar development and approval processes and developing effective communication methods to improve the understanding of biosimilars among patients, clinicians, and payers.
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 (PK) and, when feasible, pharmacodynamic (PD) data, have the potential to streamline biosimilar development programs, as comparative clinical studies are generally more costly and lengthy. To fulfill the vision articulated in the FDA’s 2018 Biosimilar Action Plan, FDA’s Office of Clinical Pharmacology and the Duke Margolis Center for Health Policy co-sponsored a public workshop in September 2021 to discuss the current and future role of PD biomarkers in improving the efficiency of biosimilar product development and regulatory approval.
As a continuation of FDA’s outreach and communication efforts, 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 mission of M-CERSI is to foster the development of regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
References:
For questions related to registration or Webex, please contact Ann Anonsen
For more information about the webinar, please contact Dr. Yow-Ming Wang
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
