Sexual HealthAARP Analysis Debunks Biologic Drug Industry Myth Association Presses Congress To Bring Less Costly Generics To Market Faster
A new analysis by AARP"s Public Policy
Institute reveals the manufacturers of many top-
selling biologic drugs have recouped average
research and development costs several times over
in the past six years, often within a single year.
The report"s finding busts the myth that allowing
generic versions of biologic drugs will undermine
further development of these breakthrough
medicines.
Unlike traditional chemical drugs, biologic drugs
are made from living organisms. The Food and Drug
Administration (FDA) has no process in place to
approve less costly generic versions of biologics,
which can cost thousands of dollars each month.
AARP"s analysis of ten top-selling biologics finds
these drugs have had U.S. sales of between $5.5
billion and $14.9 billion since 2003. The average
development cost for a new biologic drug is $1.2
billion, according to the Tufts Center for the
Study of Drug Development. All of the drugs
examined more than recovered the average
development cost of a biologic drug in just three
years of sales between 2003 and 2005.
"For more than 20 years, generic versions of
chemical drugs have given Americans access to safe,
inexpensive treatments for their health problems
without hindering scientific innovation," said AARP
Executive Vice President John Rother. "With more
Americans taking biologic drugs for relatively
common diseases like cancer and multiple sclerosis,
it"s time to bring affordable generic biologics to
the market."
AARP is telling lawmakers that a process to approve
generic biologic drugs must be a part of
comprehensive health reform. The Association has
endorsed the "Promoting Innovation and Access to
Life-Saving Medicine Act" (H.R. 1427/S. 726), which
would create a process for the approval of generic
biologic drugs. This bill would prevent generic
competition from entering the market for the first
five years after a new biologic drug is approved,
providing a common-sense balance between encouraging
innovation and increasing access to these life-
saving medicines.
Rother added: "This bill is a win-win both for
biologic drug makers and for those Americans with the
most desperate medical conditions who are struggling
to afford the medicines they need."
A competing bill, the "Pathway for Biosimilars Act"
(H.R. 1548), would force consumers to wait twelve
years before being able to purchase the lower cost
generic version of their medicine.
AARP"s report, "Biologics in Perspective: The Case
for Generic Biologic Drugs," is available here.
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