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Copycat cancer drug gets panel OK

A government panel 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 FDA usually accepts recommendations from advisory panels but isn’t required to.

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

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

Wide availability of biosimilars could significantly expand patient access to some of the most expensive, life-saving drugs on the market. Janet Woodcock, the FDA director of the Center for Drug Evaluation and Research, called the review meeting “a historic occasion.”

A small overseas market already exists for biosimilars, but the federal government is studying how to regulate the drugs here. The FDA panel’s recommendations were made as insurance companies and policymakers are increasingly scrutinizing the high cost of specialty medications.

It is unclear how biosimilars will be priced in the United States, but they cost about 20 percent to 30 percent less than the original biologic in overseas markets.

“Clearly, it’s going to have a big implication for cost,” said Mark Fleury, a policy analyst at the American Cancer Society Cancer Action Network. Fleury noted insurers have increasingly required patients to pay a higher percentage out of pocket for the highest-cost drugs, while they have to chip in less for cheaper generics.

“We fully expect the same type of behavior” when the biosimilar market is established, Fleury said.

The pharmacy benefits manager Express Scripts, which has led a crusade of sorts against high-priced drugs over the past year, projects that biosimilars will provide $250 billion in U.S. health-care savings over the next decade if 11 biologics gain biosimilar competition.

Neupogen had $1.4 billion in global sales in 2013.

Biosimilar competition will mean $5.7 billion in U.S. health savings over the next decade, according to Express Scripts projections.


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