FDA approves first biosimilar drug for distribution in the U.S.

The Food and Drug Administration has approved the first biosimilar drug for distribution in the United States, the agency announced on Friday.

The drug approved was Zarxio, a medication used to prevent infections in cancer patients receiving chemotherapy.

The approval of the first biosimilar, which are copy-cat “generic” versions of brand-name biologic drugs, comes five years after the Affordable Care Act was signed into law in 2010 by President Barack Obama.

Biologics are a type of drug made from living cells, which makes them more complex and expensive than traditional pills that are made from mixing chemicals.

Many of these “generic” biosimilars have been available in Europe for more than eight years, sold at prices up to thirty percent less than their name-brand counterparts.

The approval of the first biosimilars in the U.S. is poised to save the healthcare industry and patients $5.7 billion over the next decade, assuming a 30 percent discount, according to Express Scripts.

When biologics were first manufactured in the 1980s, biosilimar copies were thought to be impossible.

“Unlike conventional medications, biologics can’t be made by following a chemical ‘recipe.’ Dr. Leah Christl, Ph.D., Associate Director for Therapeutic Biologics, told the FDA. “For that reason, manufacturing biologics is a far more complex process than manufacturing drugs.”

Biosimilars are not identical duplicates of their brand-name counterparts the way that most other chemical generic drugs are.

Normally patent protection for medications expires, opening up the market to generic manufacturers, which provides patients with more options for less expensive medication. However until now, biologics manufacturers in America have not had to face the same open-market competition.

“Biosimilars will provide access to important therapies for patients who need them,” Dr. Margaret A. Hamburg, the commissioner of the FDA, said. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

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