Most
brand-name drugs eventually lose their patent protection, opening the
market to lower-priced generic products. But one class of drugs, known
as biologics, which includes some of the most expensive medications in
the world, has been insulated from the competition of cheaper copies for
years.
That changed when the 14 members of the panel, convened by the F.D.A.,
agreed to recommend approval of a drug known as EP2006, which helps the
body make white blood cells and is a close copy of an existing
medication called Neupogen, also called filgrastim. EP2006 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 copies of
biologic drugs to market.
“This
is kind of like cutting the ribbon to open a major new road,” said
Ronny Gal, a senior research analyst who focuses on specialty pharmaceuticals at Sanford C. Bernstein & Company. “It is literally a new concept in medicine.”
Biologic
drugs are so called because they are made out of living cells and not
synthesized from chemicals as ordinary drugs are. Some examples of
popular biologic drugs are Remicade, Humira and Enbrel for autoimmune disease, and Herceptin, Rituxan and Avastin for cancer.
If
the F.D.A. follows the panel’s advice, and it usually does, though it does
not have to, the move would usher in an era of competition for
biologics and would eventually reduce prices, Mr. Gal said.
Pharmaceutical companies have been criticized recently for the high
prices of new drugs, and biologics are particularly expensive; Avastin,
for example, can cost more than $50,000 a year.
Express
Scripts, the nation’s largest manager of prescription drug benefits,
estimates that the introduction of EP2006, to be called Zarxio in the
United States, could save $5.7 billion in drug costs over the next 10
years.
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