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FDA Approves Zarxio, The First Biosimilar Drug Cleared

Biosimilar Drug Approved

The Food and Drug Administration this week approved the first biosimilar drug for use in the U.S. The drug, called Zarxio, is designed to prevent infections in cancer patients who are taking chemotherapy.

The drug, produced by Sandoz, is a very close copy of an existing drug called Neupogen, produced by Amgen. Zarxio has been approved for use in Europe since 2009, but it has not made its way into the U.S. in part because there is no regulatory path to bring biosimilars — or approximate copies of drugs in a class called biologics — to patients.

In January, an expert panel made a unanimous recommendation that the FDA approve the drug.

[quote text_size=”small” author=”– Carol Lynch” author_title=”Global head of biopharmaceuticals and oncology injections for Sandoz”]

The FDA approal of Zarxio marks a significant milestone for the United States health care system.


The New York Times reports that the approval may pave the way for more affordable alternatives to a whole class of complex and expensive medications. The drug’s approval will help open the door to potentially cheaper lifesaving medication for millions.

Biologic drugs are made with living cells, not synthesized from chemicals like most medications. Examples of commonly used biologics include Enbrel and Remicade for autoimmune disease, and Avastin and Herceptin for cancer. Many of the most expensive drugs in the world are biologics. Until now, biologics have been mostly protected from competition from cheaper copies.

Biosimilars cost around a third of the price of brand-name biologics, on average. Some health care experts believe the discount may be up to 90%, however. Express Scripts estimates that Zarxio’s use in the U.S. may save $5.7 billion in drug costs over the next decade. If 11 biosimilars already in development are approved, the savings may top $250 billion.

The Wall Street Journal reports that companies have already discussed the development of 50 biosimilars for 15 different drugs have been discussed with the FDA. It’s believed that biosimilars may eventually account for 70% of U.S. prescriptions.

AbbiVie Inc. is one of the most vulnerable drug manufacturers to the competition from biosimilar drugs as it depends on the drug Humira for around 60% of its sales. Humira, which treats rheumatoid arthritis among other things, had $12.5 billion in sales last year, making it the best-selling drug in the world.

Several biosimilar developers such as Pfizer, Novartis and Amgen, are already gunning for some of Humira’s sales.

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