[Ip-health] Guest commentary: AMA should support distinguishable names for biosimilars

Claire Cassedy claire.cassedy at keionline.org
Fri Jun 6 13:06:55 PDT 2014

In the past Peter Pitts has been funded by big drug companies to advance
their interests on a number of issues, including measures to block access
to generic drugs.  Here he and his co-author are arguing against the use of
the same name to describe a group of products that are biosimilar.


Guest commentary: AMA should support distinguishable names for biosimilars

By Dr. Bert Petersen and Peter J. Pitts
Posted: June 6, 2014 - 1:45 pm ET

Eighty percent of all medicines sold in the U.S. are Food and Drug
Administration-approved, safe and effective generics. Our personal and
national savings are in the billions of dollars.

And here's more good news—soon there will be a new category of drugs on the
market, biosimilars. These are copies of more complicated pharmaceutical
molecules. While the price differential between a brand-name drug and its
generic copy can be upwards of 80%, biosimilar price savings will be more
modest, about 20% to 25%. Still, that's a substantial cost reduction.

Why the difference? “Biologic” medicines are large (5,000 to 20,000 atoms),
complex molecules produced from living cells. Unlike small molecule
medications made from chemical processes, biologic drugs are made by using
a living organism or its product as the starting point, which typically
produces larger molecules such as proteins or enzymes. But enough science
for right now.

Federal approval of biosimilars promises to be a very good thing, but the
devil is in the details. Unfortunately, we're seeing a disturbing trend
relating to one of those key details—nomenclature. This is no trivial
issue. It is a fact that no two biologic products produced by different
manufacturers will be the same. Therefore, how biologics are named will
directly impact the clarity of information around which products a patient
has used. Greater clarity will obviously occur if biologics and biosimilars
have distinguishable names, and that clarity will enable better safety
monitoring, timeliness in managing adverse events if they occur, and can
even help us better understand which products work better for certain
patients and specific subpopulations.

Distinguishable names provide a necessary safeguard to maximize safety and
credibility. It's really that simple—but not, it seems, for some members of
the American Medical Association.

Guest Commentary: Proper naming for biosimilars vital for patients with
rare disorders
The AMA's House of Delegates will meet June 7-11 in Chicago, and they'll be
voting on a call for nondifferential naming. In other words, asking that
biologics and their biosimilar cousins should be referred to by identical
names. That's both bad science and dangerous public policy. After all,
according to the FDA, there will be four distinct categories of biosimilars
(i.e., not similar, similar, highly similar, and fingerprint similar). The
AMA proposal doesn't even distinguish between these categories. What it
would do is purposely blur important healthcare issues for physicians and
patients, taking away doctors' ability to prescribe precisely what they
want, and hiding from patients exactly what they're getting. The dangerous
misdiagnosis is that, by calling dissimilar things by the same name, more
biosimilars will be prescribed, thus decreasing costs. It's a false promise
with dangerous consequences. Fortunately, the forthcoming debate and vote
affords the country's leading medical group the perfect opportunity to take
a firm and forceful stand against this mistaken proposition.

Let's employ some common sense here. Suppose a couple were to give birth to
a set of fraternal twins: would it make sense to name them both “Tim,” on
the grounds that it would “level the competitive playing field” as they
grew and mastered their fate? Or do the boys have the right—and the rest of
world an interest—in being able to tell them apart? And while we're on the
subject of names, let's remember that the name “biosimilar” was coined for
a reason—the products are not identical, as with fraternal twins, who are
not identical. (Even if they were—and you wanted to marry one of them—you'd
probably want your “choice” to be “informed” by their having
distinguishable names.)

Biosimilars are already available in other parts of the world. This gives
us a unique opportunity to learn from the experiences of those markets. In
Europe, where biosimilars share the same names as their originator product,
there have been an increased number of adverse events, and it can take
months for manufacturers to determine if their product caused a problem.
Days can mean lives. Months are not acceptable.

Thailand also uses nondistinguishable drug names, and that has led to a
dramatic increase in life-threatening adverse events and near futility in
efforts to track back to which products are causing specific problems.
Australia opted for distinguishable codes for all biologics, and they
appear to be experiencing successful rollout and uptake of biosimilars.

It's a universal reality: Labeling something with a distinct name is
fundamental to telling it apart from something else. Nothing more informs
American competitiveness and informed consumer choice. No entity more than
the AMA should recognize that fact-— and be its champion.

Dr. Bert Petersen is director of the Breast Surgery Clinic of St. Barnabas
Hospital in the Bronx, New York and adjunct associate professor of surgery
at the New York University School of Medicine. Peter J. Pitts, a former FDA
associate commissioner, is president and co-founder of the Center for
Medicine in the Public Interest.

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