Continuing Education Credit for this activity is no longer available.
This activity is supported by the US Food and Drug Administration (FDA) through a contract from the Department of Health and Human Services, and FDA's privacy policies apply while you are on this site.
Continuing Education Credits (CE) Released: 2/18/2016; Valid for credit through: 7/31/2019
The target audience for this course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners, pharmacists, and pharmacy technicians. The course can be taken for informational purposes or for Continuing Education (CE) credit.
Biosimilar products are a new type of biological product. In 2010, legislation gave the Food and Drug Administration (FDA) authority to approve and regulate biosimilar products for marketing in the United States. This course shares information about this important new approval pathway for biosimilar products to help participants make thoughtful and critical decisions when considering prescribing or dispensing biosimilar products. The course provides an overview of FDA's general review process in considering biosimilar product development programs.
Upon completion of this activity, participants should be able to:
Upon completion of this activity, participants should be able to:
No commercial support was received for this educational activity.
No in-kind commercial support was received for this educational activity.
The following table of disclosure information is provided to learners and contains the relevant financial relationships of each individual in a position to control the content of the course. All of these relationships were treated as a conflict of interest and have been resolved. (C7 SCS 6.1--6.2, 6.5)
| Person | Role | Relationship |
|---|---|---|
| Christopher Joneckis | Reviewer | NA |
| Daniel Brounstein | Planner, Speaker | NA |
| Daniel Orr | Legal/Policy Advisor | NA |
| Danielle Smith | Planner | NA |
| Diane Maloney | Reviewer | NA |
| Elaine Frost | Planner | NA |
| Emanuela Lacana | Planner, Reviewer | NA |
| Eric Pahon | Planner | NA |
| Joseph Cheek | Planner | NA |
| Karen Canova | Planner, Reviewer | NA |
| Leah Christl | Reviewer, Speaker | NA |
| Neel Patel | Speaker | NA |
| Nikolay Nikolov | Speaker | NA |
| Peter Adams | Speaker | NA |
| Richardae Araojo | Reviewer | NA |
| Sandra Benton | Planner, Reviewer | NA |
| Sarah Ikenberry | Reviewer | NA |
| Susan Kirshner | Speaker | NA |
| Steven Kozlowski | Reviewer | NA |
| Sue Lim | Planner, Reviewer, Speaker | NA |
To access the course, users will need a computer with an Internet connection, and:
An HTML5 capable browser is required for video playback. Occasionally, other additional software may be required such as PowerPoint or Adobe Acrobat Reader. Viewing on a desktop, laptop or tablet is recommended.
Users are required to visit all screens before getting access to the Conclusion module and the posttest. To receive your certificate for CE credit, you must complete the posttest and receive a score of 80 percent or better and complete an evaluation form.
For questions about content or about technical issues, you may contact FDA:
Toll Free
(855) 543-3784, or
(301) 796-3400
druginfo@fda.hhs.gov