Tuesday, March 17, 2015

FDA Approves Zarxio, Its First Biosimilar Drug

News Brief by Prachi Sharma
          The Food and Drug Administration (F.D.A) has recently approved Zarxio, a biosimilar drug produced by Sandoz, to prevent infections in cancer patients who are receiving chemotherapy. While Zarxio had already been approved in Europe, its approval in the United States is unprecedented as there was no regulatory system in place to bring biosimilar drugs to the market. This approval is vital as it allows increased access to these alternative drugs that are potentially much cheaper than those that are currently available.
          Biosimilar drugs utilize biologic drugs, which are made from living cells instead of chemicals like typical pharmaceuticals. Biologics are known for being extraordinarily expensive due to the lack of competition that has resulted from their patent protection. When first developed, these drugs were so complex that the development of generic versions was unfathomable. However, over the years, pharmaceutical companies have developed similar copies of these biologics and have sought approval from the F.D.A. Thus, these low-cost alternatives, which are approximately a third cheaper than brand name biologic drugs, will create newfound competition and potentially allow for some reduction in cost of older cancer care drugs. Furthermore, it is estimated that if the 11 biosimilars that are currently in development are approved, the Unites States may save approximately $250 billion in drug costs. There are still many challenges: the naming process of biosimilars as generics or brands is being debated; also, doctors may need to prescribe biosimilars because they cannot be automatically substituted for brand name drugs yet. Regardless, the FDA’s approval marks a new age for the pharmaceutical industry in the United States.

Tavernise, Sabrina, and Andrew Pollack. "F.D.A. Approves Zarxio, Its First Biosimilar Drug." The New York Times. The New York Times, 06 Mar. 2015. Web. 17 Mar. 2015.

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