Cheap, Generic 'Biologics' on the Way?
Congress Considers Allowing Companies to Make Low-Cost Copies of Drugs Like Insulin
March 8, 2007 -- High-cost drugs like insulin and new-generation rheumatoid
arthritis medications could soon become a lot cheaper. That is, if Congress can
succeed in finding a way to approve them as generics.
The issue could affect a wide range of high-priced drugs and vaccines that
are called "biologics" because they’re produced by living cells under
Insulin, a widely-prescribed biologic used by millions of people with
diabetes, can cost patients $1,500 per year. Some newer biologics used to treat
cancer can cost close to $50,000 per year. Rituxan, a biologic that targets
immune cells and treats rheumatoid arthritis and non-Hodgkin's lymphoma, can
cost more than $10,000 per treatment course.
But the FDA has no standard for proving lower-cost generic versions of
biologics equivalent to the parent drugs. That has kept them off the U.S.
Consumer groups and businesses are now calling for a standard that would let
generic companies gain government approval of copies once a brand-name
biologic’s patent expires. Such a standard, they say, could save billions in
"This is our single fastest growing category of health costs, and the
trend is simply not sustainable," Sid Banwart, a Caterpillar Inc. vice
president, told a Senate hearing Thursday.
He said the company has spent $150 million on prescription benefits last
year and that spending on biologics went up 45% since 2001.
Generic drugs can cost half of their identical brand-name "parents,"
and insurers, employers, and patients credit them with savings billions in
health costs each year. The copies are made by mimicking chemical active
ingredients in a laboratory.
But biologics contain active molecules far larger and more complex than
those in existing generics. Those molecules can’t be precisely copied
synthetically, and brand-name drugmakers closely guard information about the
delicate and complicated biological reactions needed to produce them
Brand-name drugmakers maintain that the uncertainty makes generic biologics
inherently unreliable and potentially unsafe. They want Congress to bar
biologic generics from FDA rules that let drug companies make them without
putting them through expensive human clinical studies.
"[Generic] biologics can be shown to be similar, but never identical, to
an innovator," said Jay P. Siegel, MD, president of biotechnology,
immunology, and oncology research and development at Johnson & Johnson, one
of the world’s largest manufacturers of biologics.
"You can’t just take a molecule that has never been in people ... then
all of the sudden market it to thousands of people. It’s too risky," he
Generic Companies: We Can Do It
Generic manufacturers, meanwhile, say technology now allows them to
backtrack from a biologic’s ingredients and closely approximate its molecular
structure. They accuse brand-name companies of stonewalling for fear of losing
billions in revenues.
"The science is here and has been for over a decade," said Ajaz S.
Hussain, vice president for biopharmaceutical development at Sandoz, a generic
company owned by Novartis.