Neupogen Biosimilar Coming Soon?

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Back in December we introduced you to the terms biologics and biosimilars—in a nutshell, these are specialty medications, and their (sort of) generic equivalents.

You should also know that a few pharmaceutical companies have already filed applications for biosimilar drugs, hoping for approval by the FDA and bragging rights to be the first ever biosimilar on the market in the United States.

One generic manufacturer, Sandoz, has received recommendation for approval of their application for their biosimilar, filgrastim. Filgrastim, if approved, would be highly similar to its reference product Neupogen.

What is Neupogen used for?
Neupogen is used in patients who are receiving chemotherapy to help reduce the risk of infection. Chemotherapy can cause a decrease in white blood cells (neutrophils) known as neutropenia which can lead to infection.

Neupogen works to increase the production of white blood cells in the body so that infections can be fought more effectively.

What will be the name of the new biosimilar?

The biosimilar for Neupogen will be named Zarxio.

If it is approved by the FDA, when can we expect to see Zarxio on the market?
Zarxio could be available as soon as May 2015, depending on the approval process.

Are biosimilars used in other countries?

Yes. Sandoz has been dispensing this same medication under the name Zarzio for the past 6 years in more than 40 countries.

Biosimilars, although not yet approved in the United States, are widely used across Europe as well as both Australia and Japan. There are currently close to 19 biosimilars on the market in Europe, and 8 in both Australia and Japan.

The first biosimilar in Europe was approved in 2006.

Can we expect to see other pharmaceutical companies filing applications for biosimilars?

Yes. The following medications also have potential biosimilars in the “pipeline”:

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