Comparing Biosimilars and Reference Biologic Agents
- Demonstrating biosimilarity
- Regulatory approval pathway
Clinical Considerations for Biosimilars in Rheumatology Practice
- Approved biosimilars for rheumatologic conditions
- Safety and efficacy
- Extrapolation of indication
Date / Time
Beth L. Jonas, MD
Associate Professor of Medicine
Director, Rheumatology Fellowship Program
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina
William F.C. Rigby, MD
Vice Chair, Department of Medicine
Professor of Medicine, Microbiology and
The Geisel School of Medicine at Dartmouth
Lebanon, New Hampshire
This live program will focus on the complexities of developing biosimilar products and making them available for patients with rheumatologic conditions.
The goal of this activity is to improve rheumatologists’ and other clinicians’ understanding about the emergence of biosimilars and their use in rheumatologic conditions.
This program is intended for rheumatologists, primary care physicians, nurse practitioners, physician assistants, registered nurses, pharmacists, and other healthcare professionals who are involved in the care of patients with rheumatologic conditions.
Upon completion of this activity, participants should be able to:
- Explain the similarities and differences between biosimilars, reference biologics, and small molecule generics for rheumatologic conditions
- Compare available safety and efficacy data for available biosimilars and reference biologics and the potential impact of interchangeability, extrapolation of indications, and substitution on dose/response, adverse events, and clinical outcomes
- Summarize the key steps recommended by the FDA to demonstrate biosimilarity between a biosimilar and its reference biologic
- Compare the regulatory approval pathway among a small molecule generic, reference biologic, and a biosimilar
Physician Continuing Medical Education
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine and Clinical Care Options, LLC. The Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.
The Postgraduate Institute for Medicine designates this live activity for a maximum of 0.75 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nursing Continuing Education
This educational activity for 0.7 contact hour is provided by Postgraduate Institute for Medicine.
Postgraduate Institute for Medicine is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
Pharmacist Continuing Education
Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Postgraduate Institute for Medicine designates this continuing education activity for .075 contact hour (0.1 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - ACPE UAN is 0809-9999-17-617-L04-P)
Type of Activity: Knowledge
For Pharmacists: Upon receipt of the completed activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. The existence or absence of COI for everyone in a position to control content will be disclosed to participants prior to the start of each activity.