CME: Incorporating biosimilars into practice to treat immunologic disease states: Benefits, concerns, and the present treatment landscape
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. Whereas generics are virtually identical replicas of conventional medications, biosimilars are not the same as the original product – a practically unavoidable outcome because of the considerably large molecular structure that biologics mimic. The literature suggests that learning activities focused on the evolving landscape of biosimilars, which are germane to the therapeutic area because of their potential role in cost containment. Both the FDA and medical literature independently affirm the need for clinician education on biosimilars, including: comparative efficacy; adverse event rates and management (potential concerns have included immunogenicity); regulatory guidance on interchangeability and substitution – including prescribers retaining some degree of ability to intervene in a product’s substitution at the dispensing stage; and cost considerations. There has been significant progress in the adoption of biosimilars since the first one received FDA approval over half a decade ago. Clinicians who employ biosimilars have a generally positive view of them. However, challenges remain.
Target Audience:
The following healthcare professionals: rheumatologists, gastroenterologists, and primary care physicians; physician assistants, nurse practitioners, and pharmacists who practice in the aforementioned areas of specialty; and any other healthcare professionals with an interest in or who clinically encounter patients with the immune-mediated and autoimmune disease states covered by this activity.
Commercial Support Disclosure: This program is supported by an educational grant from Coherus.
This activity is free of charge.
Release Date: January 04, 2023 -- Expiration Date: January 04, 2025
Faculty: Daniel Arkfeld, MD
Agenda
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Introduction, disclosures |
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Introduction and refresher on biosimilars, in general and in the context of immunologic health conditions • Statistics: Spending on biologics over the past decades • Definitions: Biosimilar and biosimilarity • Regulatory pathway for biologics vs. small molecules, “standalone” vs. biosimilar drug development • High-level overview of biosimilars approved by the FDA & EMA for immunologic health conditions • Manufacturing process for reference drugs and biosimilars: the differences that do exist, and the differences that don’t |
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Gaps in knowledge and practice – perceptions and misperceptions concerning: • Efficacy • Safety • Non-medical switching • Formulary status and cost • Other challenges, including patient education Patient cases |
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Biosimilars through the lens of the present and emerging treatment landscape for immune-mediated and autoimmune conditions
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Summary, conclusion, and recap |
Learning Objectives
By the end of the session the participant will be able to:
- Discuss how biosimilars differ from small molecule generic drug entities and what the regulatory steps are for their approval in the U.S.
- List specific aspects the clinician should consider when determining whether to employ a biosimilar, and apply them to a patient case.
- Recall how patients might best be educated about biosimilars for their health conditions.
- Describe the contemporary biosimilar treatment landscape, anticipated developments in the near future, and the impact biosimilars have had on patient care.
Accreditation
ACCME Activity #202373894
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 0.75 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.
ABIM MOC Recognition Statement: Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.
ABIM MOC Credit Type: Medical Knowledge
Physicians: For maintenance of certification (MOC) points, you must enter your board certification ID # and birth date correctly. 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 MOC points for this activity. By providing this data, you acknowledge that it will be shared with ACCME and the applicable certifying board. Please note: Not all activities on this site provide MOC points. If this activity does not specify that it provides MOC points in this section, then it does NOT provide MOC points. This activity provides MOC points only for ABIM.
Pharmacists
ScientiaCME is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 0.75 contact hours (0.075 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 #0574-0000-23-001-H01-P. This is an Knowledge (K)-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: Daniel Arkfeld, MD, Professor of Medicine, Division of Immunology, Keck School of Medicine, University of Southern California, has received financial compensation for speakers bureau, research, or consulting work for Amgen, BMS, GSK, Lilly, and Aurinia.
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.
Instructions
- 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.
System Requirements
Windows 7 or above
Internet Explorer 8
*Adobe Acrobat Reader
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
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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