CME/CE Information

LEARNING OBJECTIVES
Upon completion of the activity, participants should be able to:

• Describe biosimilars, follow-on biologics, interchangeability, and extrapolation of indications on the basis of FDA definitions and guidance
• Explain key aspects of current FDA guidance/processes that inform the pharmacist’s knowledge of the biosimilar approval process, manufacturing, lack of bioequivalence, labeling, and naming, as well as state regulations surrounding substitution
• Discuss the potential implications of switching between biologics and biosimilars, or between biosimilars
• Identify reliable resources on biologics and biosimilars, such as the FDA’s Purple Book and online educational tools
• Apply knowledge on biosimilars to clinical, as well as health-system/committee (e.g., formulary) and patient education situations, related to pharmacy practice

FACULTY
Adam Brufsky, MD, PhD
Professor of Medicine
Associate Chief, Division of Hematology-Oncology
University of Pittsburgh School of Medicine
Pittsburgh, PA

Ali McBride PharmD, MS, BCOP, FAzPA, FASHP
Clinical Coordinator Hematology/Oncology
The University of Arizona Cancer Center
Clinical Assistant Professor
College of Pharmacy
The University of Arizona
Tucson, AZ

Rowena Schwartz, PharmD, BCOP
Associate Professor of Pharmacy Practice
University of Cincinnati
Cincinnati, OH

ACCREDITED PROVIDER
This activity is provided by The France Foundation.

TARGET AUDIENCE
The target audience for this initiative includes Hematology/Oncology pharmacists who provide care for patients with cancer.

STATEMENT OF NEED
Hematology/oncology pharmacists serve a pivotal and highly specialized role as pertains to biosimilars, which demands a high level of expertise that informs day-to-day practice, as well as consultation with clinicians, patients, and health-system/formulary committees. However, data show that pharmacists’ knowledge of biosimilars is suboptimal and that there are, overall, misperceptions regarding these types of drugs. With well-documented deficits in knowledge and the rapidly evolving biosimilar landscape in cancer, the education of pharmacists regarding biosimilars, as well as the application of science to practice and wider opportunities for decision making in oncology, are essential.

ACCREDITATION STATEMENT
The France Foundation is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION
Pharmacists
The France Foundation is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education and will award 0.75 CEU to pharmacists who complete the activity, complete the registration and evaluation forms, and successfully pass a posttest (>70%). There is no fee to participate in this activity. This is a knowledge-based educational activity. Your CE credits will be submitted electronically to the CPE Monitor. CE providers must upload participant information within 60 days from the date the participant completed the activity. Please submit all evaluations and credit requests no later than 30 days after you complete this activity to ensure your credit fulfillment, as CE credit cannot be awarded past 60 days from the activity date. ACPE No. 0391-9999-18-097-H01-P.

DISCLOSURE POLICY
In accordance with the ACCME Standards for Commercial Support, The France Foundation (TFF) and the Hematology/Oncology Pharmacy Association (HOPA) require that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. TFF and HOPA resolve all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all their educational programs. Furthermore, TFF and HOPA seek to verify that all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards of experimental design, data collection, and analysis. TFF and HOPA are committed to providing learners with high-quality CME/CE activities that promote improvements in health care and not those of a commercial interest.

Activity Staff Disclosures
The planners, reviewers, editors, staff, CME committee, or other members at The France Foundation who control content have no relevant financial relationships to disclose.

Faculty Disclosure–Content Creators/Activity Faculty
The faculty listed below report that they have no relevant financial relationships to disclose:

• Rowena Schwartz, PharmD, BCOP

• Adam Brufsky, MD, PhD, has served as a non-CE consultant for Pfizer, Inc., Roche and Sandoz Inc., a Novartis Division.
• Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP, has served as a non-CE consultant for Amgen, Sandoz Inc., a Novartis Division and TEVA.

DISCLOSURE OF UNLABELED USE
TFF and HOPA require CME faculty (speakers) to disclose when products or procedures being discussed are off label, unlabeled, experimental, and/or investigational, and any limitations on the information that is presented, such as data that are preliminary, or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty in this activity may discuss information about pharmaceutical agents that is outside of US Food and Drug Administration approved labeling. This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. TFF and HOPA do not recommend the use of any agent outside of the labeled indications. If you have questions, contact the Medical Affairs Department of the manufacturer for the most recent prescribing information.

COMMERCIAL SUPPORT ACKNOWLEDGMENT
This activity is supported by an educational grant from Sandoz Inc., a Novartis Division.

DISCLAIMER
The France Foundation and the Hematology/Oncology Pharmacy Association present this information for educational purposes only. The content is provided solely by faculty who have been selected because of recognized expertise in their field. Participants have the professional responsibility to ensure that products are prescribed and used appropriately on the basis of their own clinical judgment and accepted standards of care. The France Foundation, the Hematology/Oncology Pharmacy Association, and the commercial supporter(s) assume no liability for the information herein.

COPYRIGHT INFORMATION
Copyright © 2018 The France Foundation. Any unauthorized use of any materials on the site may violate copyright, trademark, and other laws. You may view, copy, and download information or software ("Materials") found on the Site subject to the following terms, conditions, and exceptions:

• The materials are to be used solely for personal, noncommercial, informational and educational purposes. The materials are not to be modified. They are to be distributed in the format provided with the source clearly identified. The copyright information or other proprietary notices may not be removed, changed, or altered.
• Materials may not be published, uploaded, posted, transmitted (other than as set forth herein), without The France Foundation's prior written permission.

PRIVACY POLICY
The France Foundation protects the privacy of personal and other information regarding participants and educational collaborators. The France Foundation will not release personally identifiable information to a third party without the individual's consent, except such information as is required for reporting purposes to the ACCME.

The France Foundation maintains physical, electronic, and procedural safeguards that comply with federal regulations to protect against the loss, misuse or alteration of information that we have collected from you.

Additional information regarding The France Foundation's Privacy Policy can be viewed at http://www.francefoundation.com/privacy.

CONTACT INFORMATION
If you have questions about this CME activity, please contact The France Foundation at 860-434-1650 or info@francefoundation.com.