Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources
FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!
On Tuesday, January 25, 2022, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources. This webinar provided an intermediate overview of the scientific and regulatory basis for the biosimilar and interchangeable biosimilar approval pathway. The webinar built on past biosimilar webinars and further explores the science of biological molecules, including size, complexity, and inherent variation. In addition, we discussed the use of these products, including labeling, terminology, and pharmacy substitution. To enhance understanding, we reviewed case studies to highlight the data that can support biosimilarity and interchangeability. This webinar also demonstrated the functionality of resources available to health care professionals such as the Purple Book Database.
Instructions for Learners to complete home study activities, complete evaluation, and print certificate:
- Navigate to https://ceportal.fda.gov/
- If you have an account, please login
- If you do not have an account, click on “Create an account!”
- Once you’re logged in, please complete your profile if you haven't done so already
- Navigate to the “Web-based Courses” tab
- Select the activity you want to complete
- Click on the “Enroll” button. As you complete all the steps listed in the box, a green checkmark will appear
- Begin the activity by clicking on the link at the bottom of the page
- After viewing the presentation, click on “Complete Post-test”
- After successful completion of the Post-test, click on “Complete Evaluation”
- After completion of the evaluation, you may view/print your statement of credit and/or certificate of completion
Requirements for receiving CE credits:
Review the activity, complete the post-test and evaluation. Upon completion of all required steps, physicians, physician assistants, and nurses may view/print their statement of credit directly from the CE Portal.
Pharmacists and pharmacy technicians will need to provide their NABP e-profile ID number, as well as their DOB in MMDD format in their CE Portal Profile, in order to claim CE credit. Pharmacists and pharmacy technicians should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.
Initial release date: February 18, 2022
Expiration date: December 31, 2024