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CME: The emerging role of biosimilars in ophthalmology

Activity Description / Statement of Need:

In this online, self-learning activity:

Biosimilar drugs are products meant to be similar in quality, safety, and efficacy to an already licensed reference biotherapeutic product. There has been remarkable growth in the number of commercially available products considered biosimilar by the FDA: over 30 FDA-approved and over 20 launched by one recent count. One therapeutic area of upcoming expansion of approvals is in ocular indications, where there is considerable activere research and where available data indicate identical or near-identical rates of efficacy, safety outcomes, and immunogenicity. Biosimilars save the U.S. healthcare system $338 billion annually, a remarkable statistic for medications that are clinically interchangeable, and they are expected to continue to play a role in reducing the burden of healthcare expenditures in an era of heightened cost consciousness.

Target Audience:

The following healthcare professionals: ophthalmologists; physician assistants, nurse practitioners, and pharmacists who practice in ophthalmology; and any other healthcare professionals with an interest in or who clinically encounter patients eye disease.


Commercial Support Disclosure: This program is supported by an educational grant from Coherus BioSciences.

This activity is free of charge.


Release Date: January 16, 2023 -- Expiration Date: January 16, 2025

Faculty: Joshua Mali, MD

Agenda

Faculty introduction, disclosures

A primer on biopharmaceuticals vs. reference medications 

  • Characteristic differences in reference medications vs. biologics: molecular-level differences, composition, method of preparation
  • Definitions: biologic, biosimilar, and interchangeability

The regulatory landscape 

  • FDA regulation, action, and draft guidance
  • State laws

Cost and payer considerations

A candid assessment of ophthalmology specialist knowledge gaps: concerns about efficacy, safety, and when to use 

The present landscape of treatments for inflammatory conditions 

  • Biosimilar agents approved and under investigation for the following conditions and related data review: neovascular age-related macular degeneration and retinal vein occlusion
  • Patient education: how to discuss biosimilar concepts and options with patients 
  • Patient case(s) 
  • Future considerations

Summary, best practice recap, conclusion

Learning Objectives

By the end of the session the participant will be able to:

  • Describe biosimilar drugs, how they differ from generic drugs, the FDA process for their approval.
  • List specific aspects the clinician should consider when determining whether to employ a biosimilar.
  • Identify presently available and emerging pharmacotherapeutic treatments for management of ophthalmic disease and apply them to patient cases using evidence-based medicine.
  • Describe strategies for helping patients understand the implications of using biosimilars.

Accreditation

ACCME Activity #202378706

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education through ScientiaCME. ScientiaCME is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation: ScientiaCME designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™ toward the AMA Physician's Recognition Award. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Pharmacists

ScientiaCME is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 1.0 contact hours (0.1 CEUs) of continuing pharmacy education credit. Proof of participation will be posted to your NABP CPE profile within 4 to 6 weeks to participants who have successfully completed the post-test. Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit. ACPE #0574-0000-23-003-H01-P. This is an Application (A)-type activity. 

Pharmacists: You must enter your NABP # and birth date correctly so that proof of participation can be posted to your NABP CPE profile. It is the learner's responsibility to provide this information completely and accurately at the completion of the activity. Without providing it, the learner will NOT receive CPE credit for this activity.

Nurse Practitioners (NPs): The American Academy of Nurse Practitioners accepts AMA PRA Category 1 Credit(s)™ from organizations accredited by the ACCME. ScientiaCME will provide NPs who successfully complete each activity with a certificate of participation indicating that the activity was designated for AMA PRA Category 1 Credit(s)™.

Physician Assistants: The American Academy of Physician Assistants accepts AMA PRA Category 1 Credit(s)™ from organizations accredited by the ACCME.


Faculty Disclosure and Resolution of COI

As a provider of continuing medical education, it is the policy of ScientiaCME to ensure balance, independence, objectivity, and scientific rigor in all of its educational activities. In accordance with this policy, faculty and educational planners must disclose any significant relationships with commercial interests whose products or devices may be mentioned in faculty presentations, and any relationships with the commercial supporter of the activity. The intent of this disclosure is to provide the intended audience with information on which they can make their own judgments. Additionally, in the event a conflict of interest (COI) does exist, it is the policy of ScientiaCME to ensure that the COI is resolved in order to ensure the integrity of the CME activity. For this CME activity, any COI has been resolved thru content review by ScientiaCME.

Disclosure of Faculty: Joshua Mali, MD, Surgical Vitreo‚ÄźRetinal Specialist, Attending Physician, Manatee Memorial Hospital, has no relevant financial disclosures.

Disclosures of Educational Planners: Charles Turck, PharmD, BCPS, BCCCP, President of ScientiaCME, has no relevant financial disclosures.

Faculty WILL NOT discuss off-label uses.

All relevant financial relationships have been mitigated.

ScientiaCME 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 CE 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.

Commercial Support Disclosure: This program is supported by an educational grant from Coherus BioSciences.

Instructions

  • Read the learning objectives above
  • Take the Pre-Test (optional). Completion of the pre-test will help us evaluate the knowedge gained by participating in this CME activity.
  • View the online activity. You may view this is in more than one session, and may pause or repeat any portion of the presentation if you need to.
  • Minimum participation threshold: Take the post-test. A score of 70% or higher is required to pass and proceed to the activity evaluation.
  • Complete the activity evaluation and CME registration. A CE certificate will be emailed to you immediately.

Cultural and Linguistic Competence

System Requirements

PC
Windows 7 or above
Internet Explorer 8
*Adobe Acrobat Reader
MAC
Mac OS 10.2.8
Safari or Chrome or Firefox
*Adobe Acrobat Reader
Internet Explorer is not supported on the Macintosh

*Required to view Printable PDF Version


Perform Pre-Test (optional)

Please take a few minutes to participate in the optional pre-test. It will help us measure the knowledge gained by participating in this activity.


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