2025 JUNE CCSS S03: Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources

June 5, 2025

Target Audience

This activity provides continuing education for physicians, nurses, physician associates/physician assistants, pharmacists, pharmacy technicians, optometrists, dentists, dental hygienists, dental technicians, athletic trainers, registered dieticians, dietetic technicians, occupational therapists, occupational therapy assistants, kinesiotherapists, and case managers. A certificate of attendance is available for other attendees.

Learning Objectives

  1. Describe how biologics differ from small molecules (size, complexity, manufacturing) and explain why some biologics cannot be copied exactly.
  2. Compare and contrast the development, statutory requirements, and approval process for new biologics and for biosimilars/interchangeables.
  3. Explain the requirements for generics and biosimilars/interchangeables.
  4. Identify resources available for health care providers to learn more about biosimilar and interchangeable products through the Purple Book Database of Licensed Biological Products and other FDA educational resources.

Additional Information

Virtual COPE Course ID #: 
97761-PB
Virtual COPE Activity/Event #: 
130653
Course summary
Available credit: 
  • 1.00 AAPA

    DHA J-7 CEPO has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.00 hours of AAPA Category 1 CME credits. Approval is valid until Thursday, June 19, 2025 - 11:59pm ET. PAs should only claim credit commensurate with the extent of their participation.

  • 1.00 ACCME Non-Physician CME Credit

    DHA, J-7, CEPO is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing education. ACCME Non-Physician CME Credit providers will be provided a certificate of participation for educational activities certified for AMA PRA Category 1 Credit™. ACCME Non-Physician CME Credit providers may receive a maximum of 1.00 hours for completing this Course activity.

  • 1.00 ACPE-Pharm

    UAN: JA4008136-0000-25-053-L04-P
    No valid paper/electronic statement of credit will be offered. DHA, J-7, CEPO is accredited by the American Council for Pharmacy Education (ACPE) to provide continuing education for Pharmacists. This knowledge based activity will provide a maximum of 1.00 contact hours of pharmacy continuing education credit. Participant CE records will be electronically communicated to CPE Monitor. There is no cost to participate in this activity.

  • 1.00 ACPE-Tech

    UAN: JA4008136-0000-25-053-L04-T
    No valid paper/electronic statement of credit will be offered. DHA, J-7, CEPO is accredited by the American Council for Pharmacy Education (ACPE) to provide continuing education for Pharmacy Technicians. This knowledge based activity will provide a maximum of 1.00 contact hours of pharmacy continuing education credit. Participant CE records will be electronically communicated to CPE Monitor. There is no cost to participate in this activity.

  • 1.00 ADA CERP

    DHA, J-7, CEPO is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education (CDE). ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to the Commission for Continuing Education Provider Recognition at ADA.org/CERP.

    DHA, J-7, CEPO designates this activity for 1.00 continuing education credits

  • 1.00 AMA PRA Category 1 Credit™

    DHA, J-7, CEPO is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    DHA, J-7, CEPO designated this Course for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  • 1.00 ANCC

    DHA, J-7, CEPO is accredited by the Joint Accreditation/ Interprofessional Continuing Education (IPCE) to provide this Continuing Nursing Education Course for a maximum of 1.00 ANCC contact hours. Nurses should only claim credit commensurate with the extent of their participation in the activity.

  • 1.00 AOTA

     DHA, J-7, CEPO is an American Occupational Therapy Association (AOTA) Approved Provider of professional development (PD). PD activity approval ID# 12621. This Distance Learning-Interactive course is offered at 0.1 CEUs, intermediate, OT service delivery, professional issues, foundational knowledge. AOTA does not endorse specific course content, products, or clinical procedures.

  • 1.00 ARBO/COPE

    DHA, J-7, CEPO designates this Synchronous Virtual activity for a maximum of 1.00 COPE credit hours.

    COPE Course ID #: 97761-PB

    COPE Activity/Event #: 130653

  • 1.00 Attendance
  • 1.00 BOC

    Board of Certification for the Athletic Trainer (BOC)

    DHA, J-7, CEPO (BOC AP #: P12034) is approved by the Board of Certification, Inc., to provide continuing education to Athletic Trainers (ATs). This program is eligible for a maximum of 1.00 Category A hours/Continuing Education Units (CEUs). ATs should claim only those hours actually spent in the educational program

  • 1.00 CCMC

    This program has been pre-approved by The Commission for Case Manager Certification (CCMC) to provide continuing education credit to CCM® board certified case managers. The course is approved for up to CE contact hours.

    Activity Code: C00063476 Approval Number: 250001771

    To claim these CEs, log into your CCMC Dashboard at www.ccmcertification.org.

  • 1.00 CDR

    DHA, J-7, CEPO is a Continuing Professional Education (CPE) Accredited provider with the Commission on Dietetic Registration (CDR). CDR Credentialed Practitioners will receive 1.00 Continuing Professional Education units (CPEUs) for completion of this activity/material.

  • 1.00 COPSKT

    Provider # is 060525

    This continuing education activity has been accredited by The Council on Professional Standards for Kinesiotherapy (COPSKT) to include 1.00 contact hours/0.1 CEU. DHA, J-7, CEPO accredits enterprise-wide continuing education activities for military and civilian health care professionals. These courses are critical to DHA’s goal of providing the best possible quality care to active duty service members, veterans, and their families.

  • 1.00 IPCE

    In support of improving patient care, DHA, J-7, CEPO 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 health care team. This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credits for learning and change.

Course opens: 
05/05/2025
Course expires: 
06/19/2025
Event starts: 
06/05/2025 - 10:35am EDT
Event ends: 
06/05/2025 - 11:35am EDT
Part of: 
2025 JUNE CCSS: Evidence-Based Approaches for Advancing Excellence in Primary Care
Add to calendar: 

To view the day's presentations, join the event's MS Teams room:

https://dod.teams.microsoft.us/l/meetup-join/19%3adod%3ameeting_818cbe7d0fa845d39ee4a06d6738a00a%40thread.v2/0?context=%7b%22Tid%22%3a%228903a443-af33-4ed4-acf5-ee613bcb2f59%22%2c%22Oid%22%3a%229417ac16-7564-40a8-901b-4f24688f9a62%22%7d

 

Presenting Faculty

Headshot

Sabiha Khan, MD
Medical Officer
Office of Therapeutic Biologics and Biosimilars
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, Md.

Headshot

Sarah Ikenberry, MA
Associate Director for Stakeholder Outreach and Education
Office of Therapeutic Biologic and Biosimilars
U.S. Food and Drug Administration
Silver Spring, Md.

 
Disclosure:

DHA J-7 staff, planning committee members, faculty, and content reviewers have no relevant financial relationship(s) with ineligible companies to disclose. 
Speaker(s)

Sarah Ikenberry, MA

has no relevant financial relationships to disclose at this time.

Sabiha Khan, MD

has no relevant financial relationships to disclose at this time.

Available Credit

  • 1.00 AAPA

    DHA J-7 CEPO has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.00 hours of AAPA Category 1 CME credits. Approval is valid until Thursday, June 19, 2025 - 11:59pm ET. PAs should only claim credit commensurate with the extent of their participation.

  • 1.00 ACCME Non-Physician CME Credit

    DHA, J-7, CEPO is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing education. ACCME Non-Physician CME Credit providers will be provided a certificate of participation for educational activities certified for AMA PRA Category 1 Credit™. ACCME Non-Physician CME Credit providers may receive a maximum of 1.00 hours for completing this Course activity.

  • 1.00 ACPE-Pharm

    UAN: JA4008136-0000-25-053-L04-P
    No valid paper/electronic statement of credit will be offered. DHA, J-7, CEPO is accredited by the American Council for Pharmacy Education (ACPE) to provide continuing education for Pharmacists. This knowledge based activity will provide a maximum of 1.00 contact hours of pharmacy continuing education credit. Participant CE records will be electronically communicated to CPE Monitor. There is no cost to participate in this activity.

  • 1.00 ACPE-Tech

    UAN: JA4008136-0000-25-053-L04-T
    No valid paper/electronic statement of credit will be offered. DHA, J-7, CEPO is accredited by the American Council for Pharmacy Education (ACPE) to provide continuing education for Pharmacy Technicians. This knowledge based activity will provide a maximum of 1.00 contact hours of pharmacy continuing education credit. Participant CE records will be electronically communicated to CPE Monitor. There is no cost to participate in this activity.

  • 1.00 ADA CERP

    DHA, J-7, CEPO is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education (CDE). ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to the Commission for Continuing Education Provider Recognition at ADA.org/CERP.

    DHA, J-7, CEPO designates this activity for 1.00 continuing education credits

  • 1.00 AMA PRA Category 1 Credit™

    DHA, J-7, CEPO is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    DHA, J-7, CEPO designated this Course for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  • 1.00 ANCC

    DHA, J-7, CEPO is accredited by the Joint Accreditation/ Interprofessional Continuing Education (IPCE) to provide this Continuing Nursing Education Course for a maximum of 1.00 ANCC contact hours. Nurses should only claim credit commensurate with the extent of their participation in the activity.

  • 1.00 AOTA

     DHA, J-7, CEPO is an American Occupational Therapy Association (AOTA) Approved Provider of professional development (PD). PD activity approval ID# 12621. This Distance Learning-Interactive course is offered at 0.1 CEUs, intermediate, OT service delivery, professional issues, foundational knowledge. AOTA does not endorse specific course content, products, or clinical procedures.

  • 1.00 ARBO/COPE

    DHA, J-7, CEPO designates this Synchronous Virtual activity for a maximum of 1.00 COPE credit hours.

    COPE Course ID #: 97761-PB

    COPE Activity/Event #: 130653

  • 1.00 Attendance
  • 1.00 BOC

    Board of Certification for the Athletic Trainer (BOC)

    DHA, J-7, CEPO (BOC AP #: P12034) is approved by the Board of Certification, Inc., to provide continuing education to Athletic Trainers (ATs). This program is eligible for a maximum of 1.00 Category A hours/Continuing Education Units (CEUs). ATs should claim only those hours actually spent in the educational program

  • 1.00 CCMC

    This program has been pre-approved by The Commission for Case Manager Certification (CCMC) to provide continuing education credit to CCM® board certified case managers. The course is approved for up to CE contact hours.

    Activity Code: C00063476 Approval Number: 250001771

    To claim these CEs, log into your CCMC Dashboard at www.ccmcertification.org.

  • 1.00 CDR

    DHA, J-7, CEPO is a Continuing Professional Education (CPE) Accredited provider with the Commission on Dietetic Registration (CDR). CDR Credentialed Practitioners will receive 1.00 Continuing Professional Education units (CPEUs) for completion of this activity/material.

  • 1.00 COPSKT

    Provider # is 060525

    This continuing education activity has been accredited by The Council on Professional Standards for Kinesiotherapy (COPSKT) to include 1.00 contact hours/0.1 CEU. DHA, J-7, CEPO accredits enterprise-wide continuing education activities for military and civilian health care professionals. These courses are critical to DHA’s goal of providing the best possible quality care to active duty service members, veterans, and their families.

  • 1.00 IPCE

    In support of improving patient care, DHA, J-7, CEPO 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 health care team. This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credits for learning and change.

Please login or create an account to take this course.



Requirements: CE/CME certificates are awarded to participants who fully complete the activity, successfully submit the evaluation survey, and pass the posttest. The deadline to claim credit is Jun 19, 2025.

Access Code: Some activities require an access code to register or claim credit. Please contact the organization providing the activity for the access code. The Continuing Education Program Office (CEPO) does not provide access codes.

Accommodations: Please contact the course instructor to inquire about accommodations. For additional technical support, email [email protected].