FDA Drug Topics: Biosimilar and Interchangeable Biological Products: Basic Concepts and Practical Resources
December 17, 2019
This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, students, and other healthcare professionals, 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.
- FDA website https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval
- Purple Book: www.fda.gov/purplebooksearch
- 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
- 5. 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
- 6. 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
- Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
- Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.
- 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
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, and students other healthcare professionals.
Lecture 1 December 17, 2019
|1:00 - 2:00 PM||Biosimilar and Interchangeable Biological Products: Basic Concepts and Practical Resources||
Sarah Yim, MD
Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Pharmacists will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.
- Hann, Leila, Science Policy Analyst, FDA - nothing to disclose
- Yim, Sarah, MD, Director, Office of Therapeutic Biologics and Biosimilars - nothing to disclose
- 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
- Kapoor, Rama, MD, Medical Officer, FDA - nothing to disclose
- Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI - nothing to disclose
CE Consultation and Accreditation Team
- Lisa Thompson, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
- Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration is complimentary, therefore refunds are not applicable.
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