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9-Mar-15 12:00 PM  CST  

FDA Approval of New “Biosimilar” Drug is seen as a Positive Move Towards more Affordable Treatment Options 

On Friday, March 6th, the federal Food and Drug Administration (FDA) approved the U. S.’s first ever “biosimilar” drug, Zarxio. Many in the healthcare field and pharmaceutical industry are seeing Zarxio as a substitution for the drug Neupogen. Zarxio, like the drug Neupogen, is used to increase white blood cell counts and decrease the risk of infection among cancer patients. Patients who have been diagnosed with cancer often have debilitating decreases in white blood cell counts and until recently, Neupogen was the only option available for counteracting the decrease.

First approved in 1991, Neupogen has been effective in helping to save the lives of thousands of patients inflected with cancer, but as is the case with many life saving drugs, can also be cost prohibitive for many. According to a report from ABC News, Neupogen had U.S. sells of nearly 840 billion last year, which works out to an average cost of $3500.00 for a 30-day therapy. Novartis who manufacturers Zarxio through its subsidiary Sandoz has yet to announce the cost associated with Zarxio, but industry insiders state not only will Zarxio perform like Neupogen, but come with a much friendlier price point as well.

Recognizing a need for easier access to life saving drugs like Neupogen, the FDA lead a pathway to easier approval for “biosimilar” drugs in 2012. While “biosimilar” drugs, which is simply the pharmaceutical industry’s term for generic biotech drugs, have been used in Europe since 2006 this latest approval from the FDA is seen as a move forward in the increasing incentive to find more affordable, yet effective, means of healthcare and treatment. The FDA is expected to approve the use of a second “biosimilar” drug later in 2015 that is parallel to the Disease-modifying Antirheumatic Drugs, Humira (adalimumab) and Remicaide (infliximab), two of the most commonly prescribed drugs in the U.S.





ABC News, (2015), “ FDA Approves First Lower Cost Biotech Drug”,, retrieved 7. March 2015


Thompson, D., (2015), “Biosimilar Drug May Mean Cheaper Patient Options”, WebMD,, retrieved 7. March 2015

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For additional information on this Article article, please contact:

Kelley Simmons

Source: Sandy Andrews, CPhT, BLS

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