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  6. Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers
  1. FDA Pharmacy Student Experiential Program

Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present our FDA Drug Topic series of educational webinars targeting the needs of all health care professionals, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and certified public health professionals. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, June 20, 2023, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers. This webinar discussed the science of biological products, including size, complexity, and variation. We will describe commonalities between biosimilars and reference biological products and differences in the approval pathways, with an in-depth explanation of the scientific and regulatory concepts for biosimilars and interchangeable biosimilars. 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 the Purple Book Database and highlight resources available to health care providers about biosimilars.

Instructions for Learners to complete home study activities, complete evaluation, and print certificate:

  1. Navigate to https://ceportal.fda.gov/
  2. If you have an account, please login
  3. If you do not have an account, click on “Create an account!”
  4. Once you’re logged in, please complete your profile if you haven't done so already 
  5. Navigate to the “Web-based Courses” tab
  6. Select the activity you want to complete
  7. Click on the “Enroll” button. As you complete all the steps listed in the box, a green checkmark will appear
  8. Begin the activity by clicking on the link at the bottom of the page
  9. After viewing the presentation, click on “Complete Post-test”
  10. After successful completion of the Post-test, click on “Complete Evaluation”
  11. 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, learners may view or print their statement of credit.

For those of you who are pharmacists or pharmacy technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy—otherwise known as “NABP”—provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor.  If you do not see your credit reflected on the CPE Monitor after 45 days after completion of the activity, please contact FDACETeam@fda.hhs.gov. The CPE Monitor sets a strict 60-day limit on uploading credits.

Initial release date: August 23, 2023
Expiration date: August 21, 2026

Resources

 
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