FDA Overview of Biosimilar Products

About this site:

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

Credits Available:

Physicians – 1.5 AMA PRA Category 1 Credit(s)
Nurses – 1.5 ANCC Contact Hours
Pharmacists and Pharmacy Technicians – 1.5 ACPE Contact Hours
Nurse Practitioners – 1.5 AANP Contact Hours
Physician Assistants – 1.5 hours of Category 1 Credit

Certificates of Completion:

For users wishing to have confirmation that they have completed this course, they may choose to receive a Certificate of Completion which comes with no CE credits.

Target Audience:

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.

Description:

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.

Learning Objectives:

Upon completion of this activity, participants should be able to:

  • Identify the changes to the law granting FDA authority to review and license biosimilar products
  • Define what biological products and biosimilar products are
  • Recognize the key terminology related to biosimilar products
  • Describe FDA's general approach to the development and approval of biosimilar products

Pharmacy Technician Learning Objectives:

Upon completion of this activity, participants should be able to:

  • Define what biological products and biosimilar products are and why they differ from other small molecule drugs
  • Define the meaning of a reference and a biosimilar product
  • Describe the difference between a generic and a biosimilar drug product
  • Describe the FDA's stepwise approach to the development and approval of biosimilar products

Acknowledgement of Financial Commercial Support:

No commercial support was received for this educational activity.

Acknowledgement of In-Kind Commercial Support:

No in-kind commercial support was received for this educational activity.

Disclosure Information

The following table of disclosure information is provided to learners and contains the relevant financial relationships that each individual in a position to control the content of CE disclosed to IAHB, Amedco and FDA. All of these relationships were treated as a conflict of interest, and have been resolved. (C7 SCS 6.1-­-6.2, 6.5) All individuals in a position to control the content of CE/CME are listed below and had no relevant financial relationship to disclose.

PersonRoleRelationship
Christopher JoneckisReviewerNA
Daniel BrounsteinPlanner, SpeakerNA
Daniel OrrLegal/Policy AdvisorNA
Danielle SmithPlannerNA
Diane MaloneyReviewerNA
Elaine FrostPlannerNA
Emanuela LacanaPlanner, ReviewerNA
Eric PahonPlannerNA
Joseph CheekPlannerNA
Karen CanovaPlanner, ReviewerNA
Leah ChristlReviewer, SpeakerNA
Neel PatelSpeakerNA
Nikolay NikolovSpeakerNA
Peter AdamsSpeakerNA
Richardae AraojoReviewerNA
Sandra BentonPlanner, ReviewerNA
Sarah IkenberryReviewerNA
Susan KirshnerSpeakerNA
Steven KozlowskiReviewerNA
Sue LimPlanner, Reviewer, SpeakerNA

Accreditation Statement:

Jointly Accredited Provider LogoIn support of improving patient care, this activity has been planned and implemented by Amedco LLC and the US Food and Drug Administration (FDA). Amedco LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Credit Designation Statement:

Amedco LLC designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credit(s)™ for physicians. Learners should claim only the credit commensurate with the extent of their participation in the activity.

Nurse Credit Designation Statement:

Amedco LLC designates this enduring material for a maximum of 1.5 contact hours for nurses. Learners should claim only the credit commensurate with the extent of their participation in the activity.

Pharmacist and Pharmacy Technician Credit Designation Statement:

Amedco LLC designates this enduring material for a maximum of 1.5 knowledge-based contact hours for pharmacists. Learners should claim only the credit commensurate with the extent of their participation in the activity.

NOTE to Pharmacists and Pharmacy Technicians: The only official Statement of Credit is the one you pull from CPE Monitor. You must request your certificate within 30 days of the activity to meet the deadline for submission to CPE Monitor.

For Nurse Practitioners:

The American Association of Nurse Practitioners (AANP) recognizes the Accreditation Council for Continuing Medical Education (ACCME) and the American Nurses Credentialing Center (ANCC) as approved accreditors and allow reciprocity for AANPCP continuing education credit.

For Physician Assistants:

AAPA accepts AMA PRA Category 1 Credit(s)™ for the PRA from organizations accredited by ACCME.

Method of Physician Participation:

Each participant will listen to each audio self-directed module while following along with the visual slides. Upon completion, each physician will answer evaluation questions and pass a posttest with at least a score of 80% to receive their CE/CME certificate.

Technical Requirements and Instructions:

To access the course, users will need a computer with an Internet connection, and:

  • Internet Explorer 10 or higher,
  • Firefox 43 or higher,
  • Safari 9 or higher, or
  • Any other W3C standards compliant browser

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