Biosimilars: Implications for Clinical Practice in Inflammatory Bowel Diseases
Complimentary
Released on 11/18/21
Expires on 11/18/22
Program Description
The activity is designed to provide the latest data in diagnosis and give real-world examples and recommendations for inflammatory bowel diseases (IBD) treatment. Biosimilars are highly similar to the licensed biologics (“reference product”), with no clinically meaningful differences in safety, purity, or potency between the two products. Monoclonal antibodies and other biologic drugs play important roles in treating various IBD. However, such drugs are intrinsically more expensive to develop than small molecules, and their clinical benefits are often accompanied by challenges relating to affordability and access. Patent expiry for ‘originator’ biologics provides opportunities for a new generation of biosimilar drugs capable of relieving pressure on healthcare budgets. Biosimilars’ key characteristics include distinguishing them from generics and non-comparable biologics and outlines the robust regulatory requirements that must be followed to establish biosimilarity with a reference product.
Intended Audience
This webcast is designed to meet the educational needs of gastroenterologists, primary care physicians, physician assistants, nurse practitioners, and nurses involved in the diagnosis and treatment of inflammatory bowel diseases (IBD).
Commercial Supporter
This activity is supported by an educational grant from Amgen, Inc.
Educational Objectives
Upon completion of the educational activity,participants should be able to:
- Identify the key terminology related to biosimilar products such as interchangeability, substitution, and switching
- Assess clinical trial and real-world evidence of efficacy and safety of biosimilars in inflammatory bowel diseases
- Improve patient-provider communication patterns and participation in shared decision-making regarding appropriate use of biosimilars
Accredited Providers
Jointly provided by Amedco, a CME/CE company, and MedNet


Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by Amedco LLC and MedNet, LLC. 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.
Physicians (ACCME) Credit Designation
Designation Statement
Amedco LLC designates this enduring material for a maximum of 1.50 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nurses (ANCC) Credit Designation
Designation Statement
Amedco LLC designates this enduring material activity for a maximum of 1.50 ANCC contact hours.
Additional Credit Information
Note to 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. Maximum of 1.50 hours.
Note to Physician Assistants
AAPA accepts AMA PRA Category 1 Credit(s)TM for the PRA from organizations accredited by ACCME. Maximum of 1.50 hours.
Planners and Managers Disclosures
The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME webcast:
Kamatham A. Naidu, PhD (MedNet) has no relevant financial relationships to disclose.
Brian Waggoner (MedNet, LLC) has no relevant financial relationships to disclose.
Sheryl Morgan (Amedco) has no relevant financial relationships to disclose.
Conflicts of Interest Policy
It is the policy of the Amedco to ensure activity content is balanced, independent, objective and based on scientific best-evidence. All persons in a position to control content (i.e., course director, planning committee member and speaker) were required to disclose any relevant financial relationship with a commercial entity relative to the content of his/her presentation.
Every person in a position to control content reported he/she does not have any relevant financial relationships with industry (relative to the content of his/her presentation) to disclose.
Disclosure of Unlabeled Use
It is the policy of the Amedco to inform each speaker of his/her responsibility to disclose to the attendees when products or procedures discussed are off-label, unlabeled, experimental, and/or investigational (not FDA approved) and of any limitations on the information that is presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion.
Each speaker reported he/she will notify the audience if/when discussion includes off-label, unlabeled, experimental, and/or investigational (not FDA approved) information or limited use references within the content of his/her presentation.
Disclaimer
The information provided at this educational initiative is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.
Non-Endorsement of Products
Amedco do not imply either real or implied endorsement of any product, service, or company referred to in this educational activity.
Faculty
Miguel Regueiro, MD
Chair, Department of Gastroenterology, Hepatology & Nutrition
The Pier C. and Renee A. Borra Family Endowed Chair in Gastroenterology and Hepatology
Professor in the Department of Medicine
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University
Cleveland, OH
Dr. Regueiro discloses that he received research support form AbbVie, Janssen, Takeda, Pfizer; unrestricted educational grants from AbbVie, Janssen, UCB, Pfizer, Takeda, Celgene, Genentech; on the advisory board and consultant of AbbVie, Janssen, UCB, Takeda, Pfizer, Miraca Labs, Amgen, Celgene, Seres, Genentech, Gilead, Salix, Prometheus, Lilly, TARGET Pharma Solutions, ALFASIGMA, s.p.A; involved in CME companies such as CME Outfitters, iMedix, GI Health Foundation (GIHF), Cornerstones, Ramedy, MJH life sciences; received royalties from Wolters Kluwer Health as author/editor of UpToDate.
Christina Ha, MD
Associate Professor of Medicine
Inflammatory Bowel Disease Center
Division of Digestive Diseases
Cedars-Sinai
Los Angeles, CA
Dr. Ha discloses that she received research support from Genentech, Pfizer; educational grant from Pfizer; and on the advisory board and consultant of AbbVie, Janssen, InDex Pharmaceuticals, Genentech, Takeda, Pfizer, Bristol Myers Squibb.
Instructions
There are no fees for participating and receiving CME/CE credit for this webcast. During the period from November 18, 2021, through November 18, 2022, participants must read all the material and study the educational webcast.
This webcast includes text, graphics, and may include multimedia features.
To obtain credit, a score of 75% or better on the post-assessment is required. Please proceed with the activity until you have successfully completed this program, answered all test questions, completed the post-test and evaluation, and have received a digital copy of your credit certificate. Your online certificate will be saved on myCME within your Dashboard or Transcript, which you can access at any time.
If you have any questions relating to the accreditation of this activity, please contact the CME/CE Provider at certificate@amedcoemail.com.
If you have any other questions relating to your certificate or other issues with this activity, please contact myCME.Support@haymarketmedical.com.
Privacy Policy
Amedco observes privacy and confidentiality of CME/CE information and personal information of CME/CE participants. Third parties receive only aggregated data about CME/CE activities that are relevant to their interests and/or the activities they support.
Webcast
Time to Complete: 1.50 hours
Released: November 18, 2021
Expires: November 18, 2022
Maximum Credits:
1.50 / AMA PRA Category 1 CreditsTM
1.50 / ANCC Contact Hour(s)
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