Biosimilars in Retinal Disease

Overview

Provider Statement

This continuing education activity is provided by 

Support Statement

This activity is supported by educational grants from Biogen and Coherus BioSciences.

Activity Description

The introduction of biosimilars for the treatment of retinal diseases holds the promise of providing greater patient access to therapy and subsequently improving clinical outcomes. Biosimilars are biological therapies that are highly similar to an FDA-approved therapy, the reference product, that have demonstrated no clinically meaningful differences in safety, efficacy, or immunogenicity in clinical studies. Since 2021, ranibizumab biosimilars have been FDA approved for the management of retinal diseases, with several biosimilar candidates for ranibizumab and aflibercept currently in development. In this CE activity, experts in the field will review the development and approval process of biosimilars; discuss how these therapies have the potential to reduce barriers to treatment; and compare the safety, efficacy, and immunogenicity of approved and emerging biosimilars in the treatment of retinal disorders. Rapid-fire panel discussions will further examine practical methods and procedures that can facilitate the implementation of biosimilars into ophthalmic practice.

Target Audience

The intended audience for this activity is ophthalmologists, retina specialists, and other healthcare professionals involved in the treatment of retinal diseases.

Learning Objectives

Upon successful completion of this activity, participants should be better able to:

• Review the development and approval process of biosimilars, including how biosimilars differ from reference biologics and generic medicines.
• Recognize how biosimilars may lessen barriers to treatment, including reimbursement, insurance coverage, and limited access to treatment.
• Compare the safety, efficacy, and immunogenicity of biosimilars used to treat retinal disorders.
• Examine practical methods and procedures that can improve the implementation of biosimilars into the ophthalmic practice.

Activity Chair

Peter K. Kaiser, MD
Chaney Family Endowed Chair in Ophthalmology Research
Professor of Ophthalmology
Cole Eye Institute
Cleveland Clinic Lerner College of Medicine
Cleveland, OH

Faculty

Mark R. Barakat, MD
Director of Retinal Research Institute
Retinal Consultants of Arizona
Clinical Assistant Professor of Ophthalmology
University of Arizona College of Medicine – Phoenix
Phoenix, AZ

Susan B. Bressler, MD, FASRS
Julia G. Levy, PhD Professor of Ophthalmology
Wilmer Eye Institute
Johns Hopkins University School of Medicine
Baltimore, MD

Diana V. Do, MD
Vice Chair for Clinical Affairs
Professor of Ophthalmology
Byers Eye Institute
Stanford University School of Medicine
Palo Alto, CA

Planner/Reviewer

Ronald A. Codario, MD, EMBA, FACP, FNLA, RPVI, CHCP

Accreditation

In support of improving patient care, Vindico Medical Education 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.

Credit Designation

Vindico Medical Education designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

This enduring material is approved for 1 year from the date of original release, December 31, 2023, to December 30, 2024.

How to Participate in This Activity and Obtain CE Credit

To participate in this activity, you must read the objectives, answer the polling and pretest questions, view the content, and complete the posttest and evaluation. Provide only one (1) correct answer for each question. A satisfactory score is defined as answering 3 of the 4 posttest questions correctly. If a satisfactory score on the posttest is achieved, Vindico Medical Education will issue an AMA PRA Category 1 Credit(s)™ certificate.

Disclosures

Vindico Medical Education adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a continuing education activity, including faculty, planners, reviewers, or others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.

Relationship information is accurate at the time of content development.

Activity Chair and Faculty report the following relevant financial relationship(s)

Mark R. Barakat, MD
Consultant: AbbVie, Adverum, Alcon, Alimera, Allegro, Allergan, Annexon, Apellis, Arctic Vision, Bausch + Lomb, Biogen, CalciMedica, Clearside, Coherus, EyePoint, Genentech, IVERIC bio, Kodiak, Novartis, Ocular Therapeutix, Opthea, Outlook Therapeutics, Palatin Technologies, Regeneron, Regenxbio, RevOpsis, Roche, Stealth BioTherapeutics
Speaker Contracted by Ineligible Company: Apellis, Bausch + Lomb, Genentech, IVERIC bio, Novarits, Regeneron
Independent Research Contractor: Adverum, Annexon, CalciMedica, Clearside, EyePoint, Gemini, Genentech, Gyroscope, Kodiak, Novartis, Ocular Therapeutix, Oculis, Opthea, Oxular, Oxurion, Regenxbio, ReNeuron, Ribomic, Roche, Stealth BioTherapeutics, Unity Biotechnology
Individual Stocks and Stock Options (publicly traded): NeuBase, Oxurion
Individual Stocks and Stock Options (privately held): RevOpsis*

Susan B. Bressler, MD, FASRS
Independent Research Contractor: Amgen
Grants (paid to institution): Bausch + Lomb, Bayer, Biocon, Biogen, Boehringer Ingelheim, Genentech/Roche, Merck, Mylan, Notal Vision, Regeneron

Diana V. Do, MD
Consultant: Allergan, Apellis, Biogen, Boehringer Ingelheim, IVERIC bio, Kodiak, Regeneron
Independent Research Contractor: Boehringer Ingelheim, Regeneron, Regenxbio
Individual Stocks and Stock Options (publicly traded): Kodiak

Peter K. Kaiser, MD
Consultant: AffaMed, Alcon, Allegro, Allergan, Allgenesis, Alnylam, Alzheon, Annexon,
AsclepiX, Aviceda, Bayer, Bausch + Lomb, Biogen Idec, Bionic Vision Technologies,
Boehringer Ingelheim, Clearside , Coherus, Complement Therapeutics, DelSiTech, Dompé,
DTx Pharma, Duet Therapeutics, Eyevensys, Galecto, Galimedix, Genentech/Roche,
Glaukos, Innovent, InterGalactic Therapeutics, iRenix, IVERIC bio, jCyte, Kanaph,
Kanghong, Kera Therapeutics, Kodiak, Kriya , Nanoscope, Novartis, Ocugenix,
Ocular Therapeutix, Oculis, Ocuphire, OcuTerra, Omeros, Oxurion, Palatin, Regeneron,
Regenxbio, Resonance Medicine, RetinaAI Medical AG, Retinal Sciences, Roivant,
Samsung Bioepis, SGN Nanopharma, Stealth BioTherapeutics, Stuart,
Sustained Nano Systems, Takeda, Théa, Unity Biotechnology, Zeiss
Speaker Contracted by Ineligible Company: Allergan
Individual Stocks and Stock Options (publicly traded): Ocular Therapeutix

Planner/Reviewer reports the following relevant financial relationship(s)

Ronald A. Codario, MD, EMBA, FACP, FNLA, RPVI, CHCP
No relevant financial relationships to disclose.

Vindico Medical Education staff report the following relevant financial relationship(s)

No relevant financial relationships to disclose.

Signed disclosures are on file at Vindico Medical Education, Office of Medical Affairs and Compliance.

Unlabeled and Investigational Usage

The audience is advised that this continuing education activity may contain references to unlabeled uses of FDA-approved products or to products not approved by the FDA for use in the United States. The faculty members have been made aware of their obligation to disclose such usage. All activity participants will be informed if any speakers/authors intend to discuss either non–FDA-approved or investigational use of products/devices.

ADA Compliance

In compliance with the Americans with Disabilities Act of 1990, we will make all reasonable efforts to accommodate persons with disabilities. A text-based transcript of this lecture is available upon request. Requests should include the activity title and emailed to cme@vindicoCME.com. Requests will be honored within 3 to 5 business days.

Copyright Statement

Created and published by Vindico Medical Education, 6900 Grove Road, Building 100, Thorofare, NJ 08086-9447. Telephone: 856-994-9400; Fax: 856-384-6680. Printed in the USA. Copyright © 2023 Vindico Medical Education. All rights reserved. No part of this publication may be reproduced without written permission from the publisher. The material presented at or in any Vindico Medical Education continuing education activity does not necessarily reflect the views and opinions of Vindico Medical Education. Neither Vindico Medical Education nor the faculty endorse or recommend any techniques, commercial products, or manufacturers. The faculty/authors may discuss the use of materials and/or products that have not yet been approved by the FDA. All readers and continuing education participants should verify all information bef ore treating patients or utilizing any product.

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CE Questions?

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