FDA CME/AAPA/CNE/CPE/CPT/CPH Webinar on: Biosimilar and Interchangeable Biological Products: An Updated Review of Scientific Concepts and Practical Resources
FDA Drug Topics: Biosimilar and Interchangeable Biological Products: An Updated Review of Scientific Concepts and Practical Resources
January 19, 2021 Time: 1:00 pm to 2:00 pm (EDT)
Register here: https://collaborationcqpub1.fda.gov/content/connect/c1/7/en/events/event/shared/94630851/event_registration.html?charset=utf-8&connect-session=breezbreeze24e7qk8muxfud8e&sco-id=221479762&utm_medium=email&utm_source=govdelivery
Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. This webinar will provide an intermediate overview of the scientific concepts about biological products and the scientific and regulatory basis for the biosimilar pathway. The webinar will build on past biosimilar webinars and further explores the science of biological molecules, including size, complexity, and structure. In addition, we will review practical information regarding the use of these products, such as labeling, terminology, and pharmacy substitution. To enhance understanding, we will review a case study to highlight the data that can support biosimilarity. This webinar will also demonstrate the functionality of the enhanced Purple Book resource that is available to health care professionals.
- Purple Book: Database of Licensed Biological Products
- Cohen, H.P., Blauvelt, A., Rifkin, R.M. et al. “Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes.” Drugs 78, 463–478 (2018).
- Datta-Mannan. “ Mechanisms Influencing the Pharmacokinetics and Disposition of Monoclonal Antibodies and Peptides.” CPT Pharmacometrics Syst Pharmacol. 2017;6(9):576-588. doi:10.1002/psp4.12224.
- Walsh, G. “Biopharmaceutical benchmarks 2018.” Nat Biotechnol 36, 1136–1145 (2018).
- Guidance for Industry: Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products. November 2019.
- Oncology Drugs Advisory Committee meeting on October 10, 2018. Meeting Materials.
- Explain how to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes.
- Describe and inform health care providers of recent labeling changes which would impact prescribing and medication management to optimize patient care.
Learning Objectives: After completion of this activity, the participant will be able to:
- Describe how biologics differ from small molecules (size, complexity, manufacturing) and explain why some biologics cannot be copied exactly.
- Compare and contrast the development, statutory requirements, and approval process for new biologics and for biosimilars/interchangeables.
- Compare and contrast the requirements for generics and biosimilar/interchangeables and discuss the availability of insulin follow-on products.
- Review a case study of an approved biosimilar product.
- Describe and explain the new resources available for health care providers to learn more about biosimilar and interchangeable products through the enhanced Purple Book and other FDA educational resources.
Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students.
1:00 pm – 2:00 pm – FDA Drug Topics: Biosimilar and Interchangeable Biological Products: An Updated Review of Scientific Concepts and Practical Resources, presented by Nina Brahme, PhD, MPH, Scientific Reviewer at CDER’s Office of Therapeutics Biologics and Biosimilars (OTBB), Leila Hann, Science Policy Analyst at OTBB, and Sarah Ikenberry, MA, Senior Communication Advisor at OTBB.
Requirements for receiving CE Credit:
Physicians, physician assistants, nurses, pharmacists, pharmacy technicians, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation survey via the CE Portal (ceportal.fda.gov). Final activity evaluations must be completed within two weeks after the activity – no exceptions.
Attention Pharmacists and Pharmacy Technicians: Failure to provide your correct NABP and Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721). Do not provide your pharmacy license number. Please click the “My Account” tab and then navigate to “Edit Contact Information” to verify that your information is correct.