Physicians’ Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Physicians’ Education Resource®, LLC, designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity
Physicians' Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669 for 2.0 Contact Hours.
Not an official event of the 2017 ASCO Annual Meeting. Not sponsored or endorsed by ASCO or the Conquer Cancer Foundation.
This activity is supported by an educational grant from Mylan Inc. and Teva Pharmaceuticals.
Regency A/B is located on the Gold Level in the West Tower in the Hyatt Regency Chicago.
As the cost of cancer therapeutics steadily rises and patents on biologic therapies for oncology near their expiration, interest in the development of lower-cost biosimilar or interchangeable biological products has increased. In March 2015, the FDA approved the first biosimilar. At present, biosimilars for trastuzumab, bevacizumab, rituximab, and cetuximab are in late-phase clinical study. The complexities of biologics and their production raise practical issues for the introduction of biosimilars compared with generic versions of traditional small-molecule drugs, including their evaluation, regulation, real-world use, nomenclature, and pharmacovigilance. Many of these issues are currently being debated and addressed by the FDA. It is critical for health care providers to understand these issues and the implications of regulatory decisions and for them to be ready to evaluate biosimilars for use in their own practice. During this activity, national experts will review and discuss aspects of biosimilars important to cancer care providers, including basic scientific principles of biosimilars and their production, FDA regulatory pathways and requirements, the intricacies of clinical study design and data interpretation, biosimilar agents under investigation in hematologic malignancies and solid tumors, and practical issues related to clinical integration. To help put new information into context, this program includes several interactive faculty panel discussions and question-and-answer sessions.
This educational activity is directed toward medical oncologists. Nurse practitioners, nurses, physician assistants, pharmacists, researchers, and other health care professionals interested in the treatment of cancer are also invited to participate.
Upon completion of this activity, participants will be better prepared to:
Hope S. Rugo, MD
Professor of Medicine
Director, Breast Oncology and Clinical Trials Education
University of California San Francisco Helen Diller Family Comprehensive Cancer Center
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