The Biosimilar Name Game

  • by: |
  • 06/09/2015

From the pages of the Orange County Register

The FDA has patients playing a dangerous name game

What's in a name? In medicine, it could be the difference between life and death.

A new class of drugs is coming onto the U.S. market. Unfortunately, Congress is standing by as the Food and Drug Administration prepares to allow marketers to sell these imitations under the same name as the original drug.

The only problem is that the drugs aren't the same. The differences between the drugs, although subtle, can have serious consequences for patients' health. Lawmakers should instruct regulators to acknowledge these differences by establishing a naming system that distinguishes between the knock-offs and the originals.

The new drugs are "biosimilars." They're inexact copies of biologics – a type of complex drugs derived from living cells. Because living cell strains can't be replicated exactly, the biosimilar drug grown from these cells is also impossible to copy exactly. They're similar, but not identical – and that's the problem.

Biosimilars produced by different manufacturers have similar properties but are not identical to the original or each other.

The medical field rightly values precision, and the ability to trace side effects back to a specific drug is a crucial patient right. To protect that right, Congress should instruct the FDA to develop a clear-cut naming system that calls different medications by different names.

A study conducted in Ireland revealed important distinctions between biosimilars and the biologics on which they were based. The study found variations when Inflectra, a biosimilar that treats rheumatoid arthritis and Crohn's disease, was tested against the biologic it tried to copy. While only 5 percent of patients who received the biologic required hospital readmission, 80 percent of the Inflectra group did.

In addition, just 8 percent of the biologic patients needed multiple bumps in steroid dosage for effective treatment, but 50 percent of Inflectra patients required them. The authors of the study concluded that biosimilars might be less effective than the original biologics.

The FDA itself noted that it's first-ever commercially approved biosimilar, Zarxio, has a lower protein content than filgrastim – the original biologic. The agency dismissed the difference as a manufacturing flaw. But because biosimilars don't undergo extensive clinical trials, drug defects or harmful side effects will be detected only after they enter the market. When side effects do occur, calling different drugs by the same name would subject patients to an impossible guessing game. Did Patient A take the original filgrastim or biosimilar Zarxio?

Fortunately, the FDA's naming system is trying to address this problem. The FDA is calling Zarxio "filgrastim-sndz."

That suffix, representing the drug's manufacturer name "Sandoz," is better than no distinction, but it's still problematic. That's because a suffix shouldn't be tied to the manufacturer's name.

If Sandoz changes its name, or merges with another drug company that makes its own knockoff version of filgrastim, the four letter suffix would lose all meaning. "Sndz" is not a clear-cut differentiator that would follow a drug from patient to patient, year to year. A constant alpha-numeric suffix like "aaa123" would be considerably more effective.

The FDA must recognize that Zarxio and filgrastim are different products and have different side effects. Common sense dictates they should have different names.

Congress and the FDA need to recognize this and implement a distinct naming system before patients get hurt. Zarxio and filgrastim are almost copies of each other. But giving them the same name is akin to almost healing a patient or finding almost the right diagnosis. It's just not good enough.

Peter J. Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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