Biosimilars Basics and Beyond: Regulating Biosimilars Home Study

ACPE UAN #:  0233-9999-17-044-H04-P

Release Date:  September 20, 2017

Expiration Date:  September 20, 2018

Activity Type:  Knowledge-based  

Credit Hours:  1.0 contact hours (0.1 CEU)

Activity Fee:  There is no fee to participate in this home study activity. 

Target Audience

This knowledge-based activity has been designed to meet the educational needs of pharmacists, physicians, and nurses in managed care settings.

Activity Overview:

Biosimilars have the potential to produce significant health care cost savings in the United States and improve patient access to treatment options. Whether biosimilars are able to fulfill that potential depends in large part on how well they are accepted by payers, clinicians, and patients. The more managed care pharmacy professionals know about how biosimilars are developed, evaluated, approved, and regulated, the more likely they will be to have confidence in the effectiveness and safety of these agents.

This home study program—the second in a two-part series—focuses on legal and regulatory aspects of biosimilars, with an emphasis on recent FDA guidance documents and developments in patent litigation.

Learning Objectives 

At the completion of this activity, participants should be able to:

  1. Discuss how the FDA considers various types of data, including data from comparator products approved outside the United States, in making determination of biosimilarity.
  2. Explain why “indication extrapolation” is considered to be both acceptable and safe.
  3. Outline the FDA framework for designating the nonproprietary name of a biological product.
  4. Identify requirements and recommendations for post-marketing surveillance of biosimilars.
  5. Recognize how the stepwise procedure for resolving potential patent disputes (i.e., the biosimilar “patent dance”) affects the development, approval, and availability of biosimilars.
  6. Review state laws that could affect the use of biosimilars.

Schedule of Educational Activity

  • The FDA and Biosimilars - Gillian Woollett, MA, DPhil 
  • Federal and State Regulations for Biosimilars - Martha Rumore, PharmD, JD, MS, LLM, FAPhA

CPE Requirements:   

Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live webinar activity on September 20, 2017.  CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor.  Please allow 72 hours for processing and posting in your NABP account.

Joint Providership 

This activity is being provided jointly by Academy of Managed Care Pharmacy and PRIME® Education, LLC.


Continuing Education Credit - Pharmacists 

ACPE LogoThe Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

As an ACPE-accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of CPE activities. It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias.

Continuing Education Credit - Physicians and Nurses 


In support of improving patient care, PRIME Education, LLC (PRIME®) is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME), to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 1.0 Interprofessional Continuing Education (IPCE) credits for learning and change.

Physician Credit Designation Statement 

PRIME® designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only credit commensurate with the extent of their participation in the activity.

 Nurse Accreditation Statement 

ANCCPRIME® designates this activity for 1.0 contact hours.


To claim CME (ACCME) or CNE (ANCC) credit:

  1.    Complete the Pre-Test to assess your knowledge.
  2.    Watch the video in its entirety.
  3.    Complete the Post-Test. (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
  4.    Complete the activity evaluation.
  5.    Skip the CPE claim credit window.
  6.    Click on the Claim CME/CNE instructions document on the activities page. (Click the link within the instructions document and follow the prompts to obtain your CME/CNE certificate.)

System Technical Requirements/Viewing Requirements: System Requirements Courses and learning activities are delivered via your Web browser and Acrobat PDF. For all activities you should have a basic comfort level using a computer and navigating web sites.  View the minimum technical and system requirements for continuing education online learning activities.

Statement of Commercial Support 

This educational activity is supported by an unrestricted education grant from Sandoz, Inc. 


Christine L. Cooper, PharmD
Education Program Manager
Academy of Managed Care Pharmacy
Alexandria, Virginia

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-9999-17-044-H04-P 1 Contact Hour September 20, 2017 - September 20, 2018