drug makers are knocking on a door that never has been
opened. With a strong undercurrent brewing on several
fronts, a geopolitical storm could be raging just on
the other side.
At the center of the storm: the scientific and economic
debate over generic biologics. And while it may be years
before the biotech revolution yields its first harvest
of generic biologics in the U.S. market, manufacturers
already are working to create a scientific and regulatory
framework for just such an event.
In 2003, the U.S. Food and Drug Administration's Center
for Biologics Evaluation and Research approved 22 biological
license applications, one more than in 2002 and six
more than in 2001. Priority approvals included FluMist,
the first nasally administered influenza vaccine marketed
in the United States. Other approvals included the first
biotech products for psoriasis, asthma, Alzheimer's,
HIV/AIDS and multiple myeloma.
Analysts are forecasting a strong performance in the
sector again in 2004. "As the economy continues
in a positive direction and the industry is firmly on
its feet, we'll see a very strong performance from biotech
in the year to come," said G. Steven Burrill, chief
executive officer of Burrill & Co., a San Francisco-based
life sciences merchant bank.
While down considerably from a market capitalization
of nearly $500 billion at the height of the genomics
bubble in spring 2000, the biotech industry was still
flush with $330 billion in total market capitalization
at the end of November, up 32 percent from the start
of 2003. And, according to Sherri Cohmer at Anthem Prescription,
more than 330 biotech drugs currently are in late-stage
The hurdle for the generic industry, however, is that
there currently is no regulatory pathway in place to
bring generic biologics to market. "There is no
way to get a generic biologic on the market at this
point in the United States," said research analyst
David Buck of the Buckingham Research Group.
Last year, the Center for Drug Evaluation and Research
and CBER approved 466 new and generic drugs and biological
products combined. CDER alone approved 362 generic drugs.
The Hatch-Waxman Act, which created the framework for
more timely entry of generics into the marketplace more
than 20 years ago, pertains to drugs approved by CDER.
With the exception of insulin and human growth hormone,
which could face generic competition within the next
12 months, the majority of biologics are approved by
"We do not believe the technology is there now
to approve generic biologics," said Jeff Trewhitt,
spokesman for the Pharmaceutical Research and Manufacturers
of America. "One thing to take into account is
that with these new cutting-edge biotech and genetically
engineered drugs, there is no precedent here. It's not
like copying a traditional chemical compound.
"We're making a transition from something we know
well to something we're still learning how to use therapeutically.
These are complex new medicines. We've just begun to
scratch the surface of the iceberg," Trewhitt told
Drug Store News.
The industry ran into the same arguments in the early
1980s when generics first were being introduced to market,
said Bill Fletcher, president and chief executive officer
of Teva North America.
Teva, which last month purchased generic drug maker
Sicor, has an agreement with Savient Pharmaceuticals
to manufacture a generic form of human growth hormone
and two other unidentified products, said Fletcher,
who added that Sicor's biotech arm is looking at manufacturing
the drugs on a global basis.
Fletcher said there are various schools of thought
on how to prove a generic biologic is equivalent to
a branded biologic. "Everyone has ideas, but there
are no regulations or codification of those ideas,"
he said. "From our point of view, good science
will always be able to prove equivalency. Consumers
deserve competition in that marketplace."
It also is likely generic drug makers will be required
to conduct clinical trials to show therapeutic equivalence.
Buck told Drug Store News that generic biologics will
not hit the U.S. market until approximately 2008 to
2010, but there is the potential that the European Medicinal
Evaluation Authority may have an approval pathway for
generic biologics in place as soon as the end of this
Generic drug makers to look out for in biologics include
Sicor/Teva, Savient and Barr Laboratories, said Buck.
Some of the biotech heavy hitters that could face the
first round of generic competition include Amgen, Biogen
Idec, Eli Lilly, Genentech and Pfizer.