The Food and Drug Administration approved the U.S.’ first biosimilar product, Zarxio, on March 6. Zarxio, biosimilar to Amgen’s product Neupogen, is targeted to treat patients receiving several types of chemotherapy and patients with severe chronic neutropenia.
Here are 5 things to know about biosimilar drugs.
1. Biosimilars are approved based on similarity to another approved drug. The FDA uses another similar product, known as a reference product, to study the effects and safety of a biosimilar drug. In the case of Zarxio, the agency studied Neupogen, which was approved in 1991.
2. Biosimilars are grown in living organisms. These drugs are based on cell and DNA structure. They are grown, not chemically produced, within cells. They are usually based on a yeast or a protein.
3. Europe has been approving them since 2005. To date, the European Medicines Agency has approved 19 of them.
4. Biosimilars have been shown to target cancers, blood diseases and auto-immune disorders. Zarxio was approved to treat certain kinds of cancer and bone marrow transplant patients. The biological nature of these medicines can target the pathways of disease using proteins. Their true effectiveness and potential uses in cancer therapy are still being investigated, according to Amgen.
5. Biosimilars are not perfect copies every time. Like nature, there is variety in biomedicines. Therefore, they do not function the same way as generic, chemically-derived drugs. Minor differences are permitted as long as they show no significant differences in treatment effects, but they are clinically tested, according to Amgen.
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