|Important Event Information|
|Date:||April 13, 2022|
|Agenda:||Download the agenda|
|Speakers:||Download the speaker bios|
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.
The final agenda will be added closer to the event. The participant biographies are now available.
Register for the free webinar.
For questions related to registration or Webex, please contact Ann Anonsen: firstname.lastname@example.org.
For more information about the webinar, please contact Dr. Yow-Ming Wang: Yowming.Wang@fda.hhs.gov.
Meet the Speakers
Gary Lyman, MD, MPH, FACP, FRCP (Edin), FASCO
Professor, Cancer Prevention Program, Public Health Sciences Division and Clinical Research Division, Fred Hutchinson Cancer Research Center; Senior Lead, Health Care Quality and Policy, Hutchinson Institute for Cancer Outcomes Research; Professor of Medicine and Adjunct Professor; Public Health and Pharmacy, University of Washington and Duke University School of Medicine
Allan Gibofsky, MD, JD, MACR, FACP, FCLM
Professor of Medicine, Weill Cornell Medical College; Attending Physician and Rheumatologist, New York Presbyterian Hospital, Memorial Sloan Kettering Cancer Center, and Hospital for Special Surgery, Co-Director of the Clinic for Inflammatory Arthritis and Biologic Therapy
Gary Lichtenstein, MD, FACP, FACG, AGAF
Director of the Inflammatory Bowel Disease Center and Professor of Medicine, Gastrointestinal Division, Department of Medicine, University of Pennsylvania Hospital and University of Pennsylvania School of Medicine
Zachary Bloomgarden, MD, MACE, FASPC
Clinical Professor, Department of Medicine, Icahn School of Medicine at Mount Sinai; Editor, Journal of Diabetes
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. 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.[3,4] 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.
- Patient Protection and Affordable Care Act, Pub. L No. 111-148, Section 7002 “Approval Pathway for Biological Biosimilar Products.” Available from: https://www.govinfo.gov/content/pkg/PLAW-111publ148/html/PLAW-111publ148.htm
- US Food and Drug Administration. Biosimilars Action Plan: Balancing Innovation and Competition July 2018; Available from: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM613761.pdf
- US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Available from: https://www.fda.gov/media/82647/download.
- US Food and Drug Administration. Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. Available from: https://www.fda.gov/media/88622/download.
- US Food and Drug Administration/ Duke-Margolis Center for Health Policy. Public Workshop. Pharmacodynamic Biomarkers for Biosimilar Development and Approval (September 2021). Available from: https://healthpolicy.duke.edu/events/biosimilar.