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Definitions: biologic, biosimilar, and interchangeability The regulatory landscape  FDA regulation, action, and draft guidance State laws Cost and payer considerations A candid assessment of ophthalmology specialist knowledge gaps: concerns about efficacy, safety, and when to use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

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.

ACCME Activity #202378706

ACCREDITATION FOR THIS COURSE HAS EXPIRED. YOU MAY VIEW THE PROGRAM, BUT CME / CE IS NO LONGER AVAILABLE AND NO CERTIFICATE WILL BE ISSUED.

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‐Retinal 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.

• Read the learning objectives above
• Take the Pre-Test (optional). Completion of the pre-test will help us evaluate the knowledge 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/Linguistic Competence & Health Disparities

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