FDA Okays First Type of a New Generic

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The Food and Drug Administration has approved the first so-called biosimilar — that’s a generic version of a biologic as opposed to a chemically synthesized drug.

It’s called Zarxio and it’s adjunct medication for people getting certain cancer treatments.

It’s a near-copy of Neupogen, a lab-made version of a natural protein called granulocyte-colony stimulating factor. It boosts the production of immune system cells and helps to ward off infection in patients receiving strong chemotherapy .

“Biosimilars are likely to create greater competition in the medical marketplace,” FDA’s Leah Christl said in a statement.

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That means cheaper prices. Pharmacy benefit manager Express Scripts says Neupogen cost, on average, $3,500 a month. The new biosimilar should cost at least 30 percent less, it says.

“We have forecasted that this particular biosimilar will save the U.S. healthcare system $5.7 billion over the next decade,” Express Scripts said in a statement.

The 2010 Affordable Care Act directs FDA to quickly approve certain biosimilars.

It’s not necessarily easy to make a biosimilar. “Biologics are different from conventional medications. Conventional medications—drugs—are generally made from chemicals, or chemically synthesized, and therefore their structure can be relatively easily defined,” Christl said.

“A biosimilar is not an exact duplicate of another biologic; rather, a biosimilar is highly similar to the reference product.”

Nonetheless, more are coming. Consulting firm Avalere Health says the FDA has received four other applications from companies making biosimilars and expects to get 10 this year.


-- Maggie Fox