Zarxio approval paves way for less expensive cutting-edge medications, experts say
WebMD News from HealthDay
By Dennis Thompson
HealthDay Reporter
FRIDAY, March 6, 2015 (HealthDay News) -- The U.S. Food and Drug Administration on Friday approved the nation's first "biosimilar" drug, a move that could lead to more affordable medications for Americans who take cutting-edge biologic drugs.
This first drug, Zarxio, is considered by the FDA to be a strong stand-in for a cancer drug called Neupogen, which was originally approved in 1991.
Both Zarxio and Neupogen help cancer patients by increasing white blood cell counts and staving off harmful infections. People with cancer often experience a decrease in white blood cells, either because of the cancer itself or the cancer treatments.
Biologic drugs -- innovative medications derived from living organisms -- are paving the way for improved treatment of a number of conditions, most notably cancer, rheumatoid arthritis and psoriasis.
But biologic drugs also tend to be pricey. To combat these high costs, the Affordable Care Act authorized the FDA to create a streamlined approval process for "biosimilars" -- products that act in the same way and are as safe as existing biologic drugs.
"Biological products tend to be products that have very high prices," said Dr. John Jenkins, director of the FDA's Office of New Drugs in its Center for Drug Evaluation and Research. "With competition, one of the goals is to see, hopefully, lower prices that will make access better for the patients who need these products."
Express Scripts Inc., a prescription benefit manager, has estimated that the first two biosimilars likely to get FDA approval, versions of Neupogen and Remicade, could save U.S. patients and insurers $22.7 billion within a decade, according to the Wall Street Journal. Remicade is used to treat rheumatoid arthritis and psoriasis.
Biological products are generally derived from living cells, said Leah Cristl, associate director for therapeutic biologics in the FDA's Office of New Drugs. By contrast, traditional drugs are chemically synthesized.
Biologics can come from many sources, including humans, animals, microorganisms or yeast. Some, such as blood cells or stem cells, are extracted from living beings. Others are produced using advanced genetic technology.
source : FDA OK of 1st 'Biosimilar' Drug May Mean Cheaper Options for Patients
