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CME: Employing biosimilars in the treatment of inflammatory health conditions: How to and should I?

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.

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 inflammatory disease states covered by this activity.


Commercial Support Disclosure: This program is supported by educational grants from AMGEN.

This activity is free of charge.


Release Date: June 25, 2020 -- Expiration Date: June 25, 2022

Faculty: Jonathan Kay, MD

Agenda

Introduction, disclosures

A primer on biopharmaceuticals vs. small molecules

• Characteristic differences in small molecules 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• FDA regulation, action, and draft guidance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

• Future considerations

A candid assessment of HCP knowledge gaps

• Safety issues associated with formulations

• Safety issues associated with switching from brand to biosimilar

• Prescriber concerns

• Potential impact on patient adherence

• Counseling patients to use medication safely

The present landscape of treatments for inflammatory conditions

·  Biosimilar agents approved for the following conditions and related literature review: Inflammatory bowel disease; rheumatological conditions; plaque psoriasis

·  Efficacy

·  Safety

·  Immunogenicity

·  Patient education: How to discuss biosimilar concepts and options with patients

·  Patient case(s)

· Future considerations

· Summary, conclusion, and recap

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.
  • Describe practical considerations the clinician needs when determining whether to consider when deciding whether substituting or allowing the substitution of a biosimilar medication for its reference medication, and apply them to patient case(s).
  • Describe how biosimilars for inflammatory health conditions are impacting the treatment landscape with respect to number of treatment options, affordability, and safety considerations.
  • Identify the currently available and emerging pharmacotherapeutic treatments for management of inflammatory health conditions and apply them to patient cases using evidence-based medicine.
  • Describe strategies for helping patients understand the implications of using biosimilars.

Accreditation

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.

CME-MOC_badge

ABIM MOC Recognition Statement: Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

PhysiciansFor maintenance of certification (MOC) credit, 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 credit for this activity. Please note: not all activities on this site provide MOC credit. If this activity does not specify that it provides MOC credit in this section, then it does NOT provide MOC credit.

Pharmacists

ScientiaCME is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmaceutical education. This program is approved for 1.0 hours (0.1 CEUs) of continuing education.  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 # 0574-0000-20-023-H01-P.  ACPE Accreditation effective 6/25/2020, expires 6/25/2022. This is a Knowledge (K)-type activity. 

PharmacistsYou 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 ScientiaCME.

Faculty Disclosure: Jonathan Kay, MD, Professor of Medicine and Population and Quantitative Health Sciences,Timothy S. and Elaine L. Peterson Chair in Rheumatology, UMass Memorial Medical Center, University of Massachusetts Medical School, has received compensation as a consultant and/or researcher for Alvotech Suisse AG; Arena Pharmaceuticals; Boehringer Ingelheim; Celltrion Healthcare; Merck Sharp & Dohme; Mylan; Novartis; Samsung Bioepis; Sandoz; UCB; Pfizer; Gilead.

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

Commercial Support Disclosure: This program is supported by educational grants from AMGEN.

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.
  • Take the post-test
  • 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.