A. Biosimilars must be structurally identical to their reference biologic. B. Biosimilars may demonstrate +/- 20% difference in efficacy compared to their reference biologic. C. Biosimilars may demonstrate minor differences in clinically inactive components. D. Biosimilars may display slightly different safety profiles compared to their reference biologic, as long as these safety considerations are indicated on the prescribing label.

A. Pharmacokinetic (PK) and pharmacodynamic (PD) equivalence to reference filgrastim, based on drug serum concentration and absolute neutrophil count, respectively B. Significantly reduced incidences of antidrug antibodies over the study period compared to reference filgrastim C. Significantly higher rates of treatment-emergent adverse events that led to treatment discontinuation compared to reference filgrastim D. A significantly higher number of patients experiencing at least 1 treatment-related adverse event compared to reference filgrastim

A. Inform her that she is not an appropriate candidate to switch from the reference biologic, as biosimilar trastuzumab is only indicated for trastuzumab-naïve patients. B. Reassure her about switching because, like a generic biosimilar, trastuzumab is produced in exactly the same way as its reference drug, which means they are identical. C. Reassure her about switching and inform her that there is only minimal increased risk of infusion reaction with switching to biosimilar trastuzumab. D. Reassure her about switching and explain that biosimilar trastuzumab has gone through a rigorous approval process and no differences in efficacy or safety are anticipated.

A. Biosimilar therapies have been US Food and Drug Administration (FDA)-approved across a variety of clinical indications but are not yet incorporated into clinical practice guidelines. B. As of October 2019, no biosimilars approved by the FDA have been labeled as “interchangeable” with their reference biologic. C. Safety profiles of each approved biosimilar have been established through clinical trials, which are required as part of the FDA approval process for biosimilars. D. Efficacy profiles of each approved biosimilar indication have been established through clinical trials, which are required as part of the FDA approval process for biosimilars.