FDA Approves First Biosimilar Product: Zarxio

There is some good news for dental patients suffering from oral cancer. The U.S. Food and Drug Administration announced that Zarxio (filgrastim-sndz) has been approved as the first biosimilar product in the USA.

In order to be considered "biosimilar," the product needs to be approved as being highly similar to an already-approved biological product (known as being the reference product). It also can't have any clinically meaningful differences in terms of the safety and effectiveness from the reference product. For Zarxio, the reference product is Neupogen.

Neupogen (filgrastim) is man-made from a protein that stimulates the growth of white blood cells and helps fight off infection. Typically it is used to treat patients with a lack of white blood cells caused by cancer, bone marrow transplants, or chemotherapy.

The difference between a biosimilar product and generic medicines is that the biosimilars are large, complex molecules produced by living organism. The generic man-made products have small molecules that are produced by chemical synthesis. Biosimilars aren't new to other countries. They have been using them for quite a few years already, but it is a big step for the United States drug industry.

To learn more about this announcement, visit the maker's of Zarxio website (Sandoz) or read the full FDA press release here.


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