Free 1-hr "Live" CME/AAPA/CNE/CPE/CPT/CPH Webinar on: Biosimilar and Interchangeable Biological Products - Basic Concepts and Practical Resources sponsored by the Division of Drug Information

FDA’s Division of Drug Information is presenting a series of continuing education webinars targeting the needs of all health care professionals.

FDA Drug Topics: Biosimilar and Interchangeable Biological Products - Basic Concepts and Practical Resources Will be held on:  December 17, 2019 Time:  1:00 pm to 2:00 pm (EST) To register for the online meeting, please visit: https://collaboration.fda.gov/ddi121719/event/registration.html After registering, you will receive a calendar invitation with details on how to join the online meeting.

Activity Outline Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. This webinar will provide a brief introduction to the scientific concepts behind biologics and the scientific and regulatory basis for the biosimilar pathway. The webinar will build on past biosimilar webinars and further explores into the science of biological molecules, including size, complexity, and structure. In addition, we will review practical information regarding the use of these products, such as labeling, terminology, pharmacy substitution, and the Purple Book resource that is available to health care professionals. References: FDA website: Biosimilar Development, Review, and Approval Purple Book Gramer MJ, “Product quality considerations for mammalian cell culture process development and manufacturing” Adv Biochem Eng Biotechnol 2014, 139:123-166. Liu L, “Antibody glycosylation and its impact on the pharmacokinetics and pharmacodynamics of monoclonal antibodies and Fc-fusion proteins” J Pharm Sci 2015, 104:1866-1884. Hmiel LK, Brorson KA, Boyne MT, “Post-translational structural modifications of immunoglobulin G and their effect on biological activity” Anal Bioanal Chem 2015, 407:79-94. Berkowitz SA, Engen JR, Mazzeo JR, Jones GB, “Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars” Nat Rev Drug Disc. July 2012; 11:527-540. Series Objectives: Explain how to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes. Describe and inform health care providers of recent labeling changes which would impact prescribing and medication management to optimize patient care. Learning Objectives: After completion of this activity, the participant will be able to: Describe how biologics differ from small molecules. Explain why some biologics cannot be copied exactly. Compare and contrast the development and approval process for new biologics and biosimilars/interchangeables. Recognize the differences in the statutory requirements for approval between new biologics and biosimilars or interchangeables. Describe and explain the resources available for health care provider to learn more about biosimilar and interchangeable products through the enhanced Purple Book. Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students. Schedule: 1:00 pm - 2:00 pm – FDA Drug Topics: Biosimilar and Interchangeable Biological Products: Basic Concepts and Practical Resources presented by Sarah Yim, MD, Acting Director, Office of Therapeutic Biologics and Biosimilars, and Leila Hann, Science Policy Analyst, Office of Therapeutic Biologics and Biosimilars.

Continuing Education: Accreditation:

In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians and physician assistants should claim only the credit commensurate with the extent of their participation in the activity. CPE This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-19-020-L04-P, and ACPE Universal Activity Number JA0002895-0000-19-020-L04-T for 1.00 contact hour(s). CNE FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).

AAPA

This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation.

CPH Up to 1.00 CPH Recertification Credits may be earned at this event. Requirements for receiving CE Credit: Physicians, physician assistants, nurses, pharmacists, pharmacy technicians, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation survey via the CE Portal (ceportal.fda.gov). Final activity evaluations must be completed within two weeks after the activity - no exceptions. Pharmacy participants: Pharmacists and pharmacy technicians will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.   Important Note regarding completion of evaluations and receiving credit: Attendees have 14 days from the last day of the activity to log in, attest to your attendance, and complete the required evaluation survey, to claim credit. Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the activity to obtain their CE credit. Disclosure: Faculty: Hann, Leila, Science Policy Analyst, FDA - nothing to disclose Yim, Sarah, MD, Acting Director, Office of Therapeutic Biologics and Biosimilars - nothing to disclose Planning Committee: Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose Cao, Christian, MPAS, PA-C, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV - nothing to disclose DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose Kapoor, Rama, MD, Medical Officer, FDA - nothing to disclose CE Consultation and Accreditation Team: Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose Thompson, Lisa, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose Registration Fees and Refunds: Registration is complimentary therefore refunds are not applicable. Please direct your comments or questions via email to DDIWebinars@fda.hhs.gov. To learn more about future dates and registration, please visit: www.fda.gov/DDIWebinars.