Trastuzumab-dttb Biosimilar FDA Approved for Breast Cancer

The FDA recently approved the biosimilar trastuzumab-dttb (Ontruzant®, Samsung Bioepis Co, Ltd) at a multi-dose of 420 mg for treating patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer. Biosimilars are biological agents made from living organisms and are "similar" to another biologic drug that is already FDA approved. Trastuzumab-dttb, a biosimilar that references trastuzumab (Herceptin®, Genentech), has been previously approved by the FDA at a 150 mg sin...
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Survey of Oncology Nurses Reveals Knowledge Gaps Surrounding Biosimilars

A biosimilar is a biological agent that is very much like another previously FDA-approved biological agent, called the reference drug. Biosimilars and their reference drugs are both made from living organisms, but they may be made in different ways and of slightly different substances. A biosimilar must demonstrate the same safety and efficacy and work in the same way as the reference drug, and it must also be used in the same way, at the same dose, and for the same condition. There are currentl...
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Biosimilars in Oncology: An Interview With Eric Zack, DNP, RN, ACNP-BC, AOCN®, BMTCN®

Biosimilars—a biologic that is "similar" to another biologic drug that is already FDA approved—are becoming more common to prescribe to patients with various conditions. It is crucial for health care providers to keep abreast of the current information regarding biosimilars. To help educate oncology nurses on this emerging field, Eric Zack, DNP, RN, ACNP-BC, AOCN®, BMTCN® and colleagues created an intervention including an overview of the history of biosimilars and information about the biosimil...
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Pegfilgrastim Biosimilar One Step Closer to FDA Approval

The pharmaceutical company Sandoz recently resubmitted its Biologics License Application to the FDA for a proposed pegfilgrastim biosimilar. Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia, a side effect of chemotherapy that kills 4,000 cancer patients every year in the United States. A biosimilar is a drug made up of living organisms that is "similar" to another biologic medicine (considered to be the reference product) that is already FDA approved. A ...
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Trastuzumab Biosimilar Approved for Breast Cancer

Trastuzumab-pkrb (Herzuma®, Celltrion Inc.) has recently been FDA-approved to treat human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer. Trastuzumab-pkrb is a biosimilar to trastuzumab (Herceptin®, Genentech Inc.). Biosimilars—biological agents made from living organisms—are almost identical to another biological agent that has already been FDA-approved, known as the reference drug. Biosimilars and their reference drugs may differ in production and composition; however, ...
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