Program Slides Download (PDF) (Coming Soon)
In the next few years, a new generation of agents, the complex biosimilars, will be available in the United States (US) as biologics begin to lose their patents. Outside the US, experience with biosimilar products has grown in recent years. Current European Union (EU) biosimilars have been approved for multiple sclerosis; symptomatic anemia associated with chronic renal failure; symptomatic anemia in patients receiving chemotherapy for solid tumors, malignant lymphoma, or multiple myeloma; neutropenia; and autoimmune diseases (rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriasis).
The latest approval was infliximab, the first monoclonal antibody biosimilar to be approved for the treatment of inflammatory conditions. In March 2015, the Food and Drug Administration (FDA) approved the first biosimilar drug for the US market. Several other agents are either undergoing FDA review or will undergo FDA review soon. As they are incorporated into clinical practice, it will be necessary for healthcare professionals to have a thorough understanding of the clinical considerations associated with prescribing these agents to patients, so that the ultimate goal of increased patient accessibility to safe and effective treatments is achieved.
Edward Li, PharmD, MPH, BCOP
University of New England College of Pharmacy
Ali McBride, PharmD, MS, BCPS
University of Arizona Cancer Center
This activity is intended for pharmacists providing care for and/or making treatment decisions for cancer patients, nephrology patients, hematology patients, and patients with inflammatory rheumatologic, gastrointestinal, and dermatologic diseases.
At the conclusion of this activity, participants should be able to demonstrate the ability to:
• Identify the key differences between biosimilars, biologics, and generics as pertaining to production, regulatory requirements, and costs
• Evaluate the rationale for the use of biosimilars in patient care
• Assess the totality of the evidence of biosimilar agents for oncology, hematology, and inflammatory disease
• Review current United States (US) and out-of-US experiences with biosimilars
- Welcome and Introduction
- The Standards for Approval of Biosimilars – A Focus on Patient Access and Safety
- Evaluating Data and Incorporating Biosimilars in Clinical Practice – Experiences from Other Countries and Applications in the US
- Conclusions and Final Q&A Session
The Potomac Center for Medical Education is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
The Potomac Center for Medical Education designates this educational activity for a maximum of 1.5 hours (0.15 CEUs) of continuing education credit (UAN number 0418-9999-15-001-L01-P).
This is a knowledge-based activity.
For questions regarding CEU credit, the post-test, or evaluation, please email firstname.lastname@example.org.
Potomac Center for Medical Education (PCME) adheres to the policies and guidelines set forth to providers by the Accreditation Council for Pharmacy Education (ACPE), the Accreditation Council for Continuing Medical Education (ACCME), and all other professional organizations, as applicable, stating those activities where continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous.
All persons in a position to control the content of a continuing medical education program provided by PCME are required to disclose any relevant financial relationships with any commercial interest to PCME as well as to learners. All conflicts of interest are identified and resolved by PCME in accordance with the Standards for Commercial Support in advance of delivery of the activity to learners.
The content of this activity was vetted by an external medical reviewer to assure objectivity and that the activity is free of commercial bias.
Method of Participation
To complete the activity and receive ACPE electronic credit, the participant must attend the program and provide their NABP e-Profile number along with their month/day (MMDD) of birth on their completed evaluation form.
There are no fees associated with this program.
Event staff will be glad to assist you with any specials needs (e.g. physical, dietary, etc.).
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Seating is limited.
Food and beverage are no longer provided at Midday Symposia. This ASHP policy considers the varied internal policies of commercial supporters related to the Physician Payments Sunshine Act. You are welcome to bring your lunch to the session.
Jointly PROVIDED By
Jointly Provided by Potomac Center for Medical Education and Rockpointe.
This activity is supported by an independent educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.