SOURCES: March 6, 2015, news conference with John Jenkins, M.D., director, U.S. Food and Drug Administration Office of New Drugs, Center for Drug Evaluation and Research; Leah Christl, Ph.D., associate director, therapeutic biologics, FDA Office of New Drugs; The New York Times; Wall Street Journal
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.
"It is important to note that a biosimilar is not just like a generic drug," Christl said. "Because of the differences in complexity of the structure of the biologic and the process used to make a biologic, biosimilars are not as easy to produce as generics, which are copies of brand name drugs."
A biosimilar is not an exact duplicate of a biologic, she said. Rather, a biosimilar is highly similar to the biologic drug it is meant to replace.
To approve Zarxio and any future biosimilar drugs, the FDA must show through lab tests that the drugs are processed by and function inside the human body identically to the original biologic drug, which the agency refers to as the "reference product," Jenkins said.
Biosimilar drugs do not have to go through the rigorous clinical trial procedure that the original biologic drugs had to endure to receive approval, he said. However, the manufacturers must show that they work the same way and share the same dosage and strength of the original biologic.
"We're not trying to re-prove safety and efficacy. That's already been demonstrated for the reference product," Jenkins said. "We're trying to show that the products are highly similar, and there's no difference in how they behave when administered to humans."
The FDA currently is reviewing approval applications of at least four other biosimilar drugs, Christl said.
Zarxio, an injectable drug manufactured by Sandoz Inc., a unit of Novartis AG, has been available in Europe as Zarzio since 2009, according to The New York Times. It has not been used in the United States because, prior to the Affordable Care Act, no regulatory pathway existed for approval of biosimilar drugs, the FDA said.
The FDA has assigned the generic name "filigrastim-sndz" to Zarxio. Neupogen, called filigrastim, is manufactured by Amgen Inc.
To learn more about biosimilars, visit the U.S. Food and Drug Administration.