Consumer Reports / Steve Mitchell / August 08, 2016
Similar versions of original pricey treatments for rheumatoid arthritis
could save consumers billions
Remicade, Enbrel, and Humira can help relieve rheumatoid arthritis, psoriasis, and inflammatory bowel disease, but these biologic
drugs can easily cost thousands of dollars a month out of pocket.
Less-expensive versions of these, known as biosimilars, could be an option, and
three could be headed to the market soon: A Remicade biosimilar was approved in
April, and a Food and Drug Administration advisory committee recommended
approving biosimilars of both Enbrel and Humira in July.
But some patient and physician groups have questioned whether
biosimilars are as safe and effective as their brand-name counterparts. That’s
because biologics contain proteins and often other compounds that can’t be
replicated exactly, which means that a biosimilar is a close match but not
identical to a biologic.
A new analysis published August 2 by the Annals of Internal
Medicine should help put some of those concerns to rest.
The study,
by researchers at Johns Hopkins Bloomberg School of Public Health in Baltimore
and Brigham and Women’s Hospital in Boston, found that biosimilars have the
same safety and effectiveness as their corresponding brand-name biologic.
That’s important for you, because biosimilars are expected to cost up to 40
percent less than brand-name counterparts, a savings projected to amount to
billions of dollars over the next several years, according to separate analyses
by the RAND Corporation and Express Scripts.
To find out how biosimilars stacked up to the brand-name drugs,
the new study looked at 19 clinical trials and other studies that were used to
get biosimilar versions of Remicade, Enbrel, and Humira approved in the U.S.,
Europe, and other countries. Almost all of the participants in the studies,
which looked at adverse effects, effectiveness, and how the medications are
absorbed and metabolized in the body, were healthy volunteers or people with
rheumatoid arthritis.
“Our results
suggest that, for this important class of drugs, the biosimilar versions appear
to have the same safety and efficacy profiles as their branded counterparts,”
says Caleb Alexander, M.D., an author of the study and a co-director of the
Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School
of Public Health.
“This is great
news for patients, because these products will force prices down on this common
and costly used class of biologic therapies, and ultimately save patients,
insurers, and the health system billions of dollars,” Alexander adds.
It could be a
while before biosimilars become available. That's because the manufacturers of
the original, brand-name biologics are challenging the biosmiliar
manufacturers' patents in court, delaying the launch of the less-expensive
biosimilars.
That's what's
happening with the biosimilar, Inflectra, the generic version of Remicade. It
was approved in the U.S. in April, but its launch is delayed due to an ongoing
patent challenge.
The FDA hasn’t
yet approved the biosimilars of Enbrel and Humira, but both are already
embroiled in patent challenges by the brand manufacturers.
Editor's Note: These materials were made possible by a grant from the state
Attorney General Consumer and Prescriber Education Grant Program, which is funded
by a multistate settlement of consumer fraud claims regarding the marketing of
the prescription drug Neurontin (gabapentin).
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