The FDA
has approved the first so-called biosimilar drug for use in the United
States, paving the way for less expensive alternatives to an entire
class of complex and costly drugs.
The drug, called Zarxio, produced by Sandoz, is used to help prevent infections in cancer patients receiving chemotherapy.
It is a close copy of an existing medication called Neupogen, made by
Amgen. It was approved in Europe in 2009 as Zarzio but has not been used
in the United States, in part because no regulatory pathway existed to
bring biosimilars, approximate copies of drugs in a class known as
biologics to market.
“Biosimilars
will provide access to important therapies for patients who need them,”
Dr. Margaret A. Hamburg, the commissioner of the F.D.A., said in a
statement.
The
approval is significant because it opens the door to a new class of
potentially cheaper lifesaving drugs for millions of Americans. It
involves biologic drugs, which are made using living cells and not
synthesized from chemicals like typical drugs. Some popular biologic
drugs are Remicade and Enbrel for autoimmune diseases, and Herceptin and Avastin for cancer. Some of the world’s most expensive medications are biologics.
Express Scripts estimates that Zarxio’s introduction in the United
States could save $5.7 billion in drug costs over the next 10 years. It
estimated that $250 billion in drug costs could be saved over the next
decade if 11 biosimilars in development were approved.
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