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Biosimilars in the United States: Considerations for Oncology Advanced Practitioners
Journal of the Advanced Practitioner in Oncology (04/01/2015) Vol. 6, No. 2, P. 108; Mayden, K.D.; Larson, P.; Geiger, D.
The development of U.S. policies for biosimilars and the drugs' increasing use means that advanced practitioners should receive thorough, ongoing education about them. Specific areas for this education include the differences from small-molecule drugs; the unique approval pathways for biosimilars; evaluations of quality, safety, and efficacy; ongoing safety monitoring; and product identification for efficient safety reporting. Nurse education should place emphasis on the differences between biosimilars and the reference product, such as approved indications. It also should include assessment of substitutions, monitoring for adverse events, and the need for documentation for safety reports. When educating patients on biosimilars, advanced practitioners should note the differences between the biosimilar and reference product regarding their administration, handling, and storage, as well as the need for self-monitoring in case of adverse events.
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