A drug naming dispute, with billions on the line


(Flickr user Images Money)

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In health care, even how you name something can become a debate with billions of dollars on the line.

With a new wave of cheaper versions of biologic drugs expected to soon become available in the United States, the health-care industry is still fighting over key ground rules for these drugs — more than four years after the Affordable Care Act cleared a pathway for this new drug classification. That includes what names these copy-cat version of biologic drugs should actually go by.

Biologics, which treat serious diseases like cancer and multiple sclerosis, are usually more expensive than conventional drugs, and they're also harder to make. Unlike traditional drugs made from chemicals, biologics are made from the proteins of living organisms. So that also makes it impossible to exactly duplicate biologics, but copy cat "biosimilars" are near-replicas of these drugs and have been selling at about 20 percent to 30 percent lower than the biologic price in foreign markets.

Biosimilars are still waiting to break into the United States, though. By one estimate, the U.S. market for these drugs will grow from virtually nothing to $36 billion by the end of the decade. Faster adoption of these biosimilars in the United States could amount to hundreds of billions of dollars in savings for the health-care system, according to estimates from the pharmacy benefits manager Express Scripts. How quickly they're adopted, though, will depend on policies that are still being decided — like the naming issue.

The question comes down to this: Should biosimilars be allowed to share the same as the biologics they're substituting, similar to the way generic drugs share an identification with the brand-name product. The answer to this question will likely help determine how widely biosimilars will be used when they're approved in the United States.

Stakeholders over the past few weeks have been making their cases to the Food and Drug Administration over the naming policy. Generic drugmakers, Express Scripts and 30 other groups last month called on the FDA to allow biologics and the copy-cat biosimilars to share a name, pointing to practices in other countries where the drugs are already available.

"Patients, prescribers and dispensers of these drugs need to be able to easily identify which drugs bear a relation to one another in order to maximize the potential savings from the biosimilar approval pathway," the groups wrote last month.

Not everyone feels the same way, though. Just last week, 10 groups representing specialty physicians urged the FDA to require unique names for biosimilars, citing the difficulty of trying to copy the original biologics among other reasons. "Distinct nonproprietary names will help to alert physicians that each product, while safe and effective, may differ slightly," they wrote.

A few Senators earlier this month asked FDA to clarify the naming issue after the regulatory agency accepted its first-ever application for a biosimilar. So there may be more clarity on this issue — and the billions of dollars at stake — soon.

Correction: An earlier version of the story said biosimilars were selling at 20 percent to 30 percent of the biologic price in foreign markets. They're actually selling at a discount of 20 percent to 30 percent.

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Jason Millman covers all things health policy, with a focus on Obamacare implementation. He previously covered health policy for Politico.
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