Target Audience and Goal Statement

This activity is intended for medical oncologists, hematologists, nurses, pharmacists, and other clinicians involved in the care of patients with cancer.

To date, 8 biosimilars have been approved by the FDA, and more are expected to be approved as a means of controlling rising medical costs. To be approved, a biosimilar must show "no clinically meaningful differences" to the approved biologic with the same mechanism of action, route of administration, dosage form, strength, and indications as the reference biologic. In addition, "interchangeable" biologics are biosimilars that have demonstrated similar efficacy in patients and can be automatically substituted for branded biologics.

However, many physicians have lingering concerns about safety, efficacy, formulations, and formularies with biosimilars. "From Biologics to Biosimilars in Oncology Practice" will review the documentation process of biosimilars and provide comparisons of evidence between biosimilars and their reference biologics. The activity will also cover cost-comparison scenarios, review the development and approval process, and explore factors that are likely to impact the assimilation of biosimilars into the treatment paradigm.

Upon completion of this activity, participants will be able to:

1. Understand the differences between biosimilar and generic products and between biosimilar and originator biologic therapies, including clinical data (ie, pharmacodynamics and safety) needed for biosimilar approvals compared to originator biologics
2. Mitigate potential clinical barriers to the adoption of biosimilar agents in community cancer centers
3. Discuss administrative and cost barriers to biosimilar implementation, including impediments to healthcare coverage and reimbursement