Biosimilars Coming to the Market?

Published January 12, 2015

The use of generic medicines has dramatically reduced the cost of prescription drugs in this country. It now looks like ‘biosimilars,’ which are roughly speaking generic versions of biological medicines, may finally be coming to the market in the U.S.

From the Washington Post last week:

The cheaper cancer drug that could pave the way for much more affordable medicine

A government panel Wednesday took a major step toward approving a copycat version of a blockbuster cancer drug, paving the way for a new class of cheaper medicines that could save consumers billions of dollars.

An expert Food and Drug Administration panel unanimously recommended that the government approve the drug known as EP2006, a lower-cost imitator of a popular medicine called Neupogen, used to help cancer patients fight off infection while undergoing chemotherapy…

The drug, manufactured by Sandoz, could win final FDA approval this year, which would make it the first biosimilar, as such drugs are known, to enter the United States. Biosimilars are versions of complex biologic drugs, which are produced from living cells and more expensive and harder to manufacture than ordinary chemical drugs.

These drugs are frequently used to treat cancer and other complex diseases that can result in astronomically high medical bills. Popular biologic drugs include Rituxan and Avastin for cancer and Humira for auto­immune disease…

Assuming EP2006 is approved, and is followed by other approvals for biosimilars, the cost savings in U.S. health care could be enormous. Estimates cited in the story are between $44 billion (Rand Corporation) and $250 billion (Express Scripts) over ten years, and the price of biosimilars is about 20 to 30 percent lower where they are available overseas than the original drug.

I should also note that this good news is a result of the Affordable Care Act, which included language directing the FDA to create an approval process for biosimilars. There’s not many things in the law to like, from my perspective, but this is one of them.