FDA approves 1st biosimilar drug

On Friday, the Food and Drug Administration approved what's called a biosimilar version of the cancer drug Neupogen. A recent study estimates biosimilar drugs could save Americans $44 billion dollars over the next ten years.

Joseph Manghan, 20, has an advanced form of a rare cancer called Ewing sarcoma. Following his chemotherapy, he gets injections of Neupogen, a drug that helps bolster his immune system.

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Even with insurance coverage, Ewing sarcoma patient Joseph Manghan and his mother have spent $1,200 in the last eight months on Neupogen, a biologic medication to boost his immune system.
CBS News

Manghan is covered under his mother's health insurance, but over the past eight months, the Neupogen alone has still cost them $1,200 out of pocket.

"The Neupogen itself, I know, puts a huge strain on our finances," Mangahan says.

Neupogen is a biologic -- a drug created using living cells, which makes it a more targeted form of treatment than a conventional drug. But what makes it so powerful also makes it hard to copy.

Generic versions of conventional drugs are exact duplicates. Generic versions of biologics -- called biosimilars -- are closely related, but not identical.

"If we think of a generic like maybe building a townhouse, Neupogen is like building a skyscraper," says Dr. David Henry of the Abramson Cancer Center at Pennsylvania Hospital in Philadelphia. "It's much more complicated, many more pieces in place."

Because biosimilars are not exact matches of the original, some question whether they'll be as safe and effective as their branded predecessors. Dr. Janet Woodcock oversees the approval process at the FDA.

"We are very confident," Woodcock says. "If we approve a biosimilar, we are saying we expect to see the same effects, benefits and, unfortunately, side effects as the reference brand drug.'"

Widely used biologic cancer drugs like Avastin and Herceptin can now cost up to $70,000 a year. Less-expensive biosimilar versions of those medications are already in the works.

  • Jonathan LaPook

    Dr. Jonathan LaPook is the chief medical correspondent for the CBS Evening News. Follow him on Twitter at @DrLaPook