Biosimilars in the United States: Considerations for Oncology Advanced Practitioners

Biosimilars will enter the US market soon, potentially lowering costs and increasing patient access to important oncology biologics. Biosimilars are highly similar, but not identical, to their reference product. Subtle variations arise due to their inherent complexity and differences in manufacturing. Biosimilars are not generic drugs. They will be approved through a separate US regulatory pathway—distinct from conventional biologics license applications—based on analytic and clinical studies demonstrating no clinically meaningful differences from the reference product. As policies on US biosimilars evolve, it is important that advanced practitioners receive comprehensive, ongoing education on them, particularly regarding differences from small-molecule drugs; their approval pathways vs. conventional regulatory pathways; evaluation of quality, safety, and efficacy; safety monitoring; and product identification to facilitate accurate safety reporting. Advanced practitioners will play a key role in educating nurses and patients on biosimilars. Nurse education should highlight any differences from the reference product (e.g., approved indications and delivery devices) and should emphasize assessment of substitutions, monitoring for adverse events (e.g., immune reactions), and the need for precise documentation for safety reports. Patient education should address differences between the biosimilar and reference product in administration, handling and storage, and self-monitoring for adverse events.