Biosimilars: Implications for Clinical Practice in Inflammatory Bowel Diseases

Complimentary

Released on 11/18/21
Expires on 11/18/22

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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.

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