flu and biosimilars
After a gap of few years, yet another virus
scare has threatened to engulf the world. The latest outbreak has been
caused by the H1N1 virus, a relatively new strain of the influenza
virus. It belongs to the same family of H1N5 virus, or the bird flu and
the SARS virus that wreaked havoc in some parts of the world in the
last five years.
Of course, the world is better prepared this time to handle the crisis.
The global attention is also more because the H1N1 virus has infected
people in the US, Canada, Germany which are some of the
world’s most affluent countries. The origin of the outbreak
has been traced to Mexico where nearly 200 people have died. Because of
the high profile of the countries affected, the World Health
Organization (WHO) has drummed up a high pitched campaign and
governments around the world have launched surveillance and preventive
The SARS and bird flu outbreaks were also touted to engulf the world.
But they were contained quickly even though the most affected countries
were China and her Asian neighbors. The lessons learnt from these two
earlier outbreaks will come in handy to contain the swine flu which has
been renamed by WHO as H1N1 influenza, to prevent any damage to the
powerful pork industry in the US. Leading governments have cranked up
the production of only known cure against the virus, Oseltamivir, known
by its popular brand name, Tamiflu.
More importantly, the innovator of Tamiflu, Roche had licensed Hetero
Drugs in Hyderabad, India and few other companies in Africa to boost
production capacity and increase stockpiles with health care agencies
around the world. Generics companies like India’s Ranbaxy and
Cipla too have their own versions of Tamiflu and have offered to
produce large quantities of the drug to meet any global emergency.
Clearly, the frequent global scares created by the influenza virus has
helped to soften the opposition to generics drug manufacturers. In
fact, these periodic episodes have brought more respectability to
generics drug makers as any distressed society will be
appreciative of the cure providers even if they are generics drug
May be the time is right for the entry of biosimilar drugs in the
world’s largest market, the US, which had resisted
it so far. The world’s largest biopharmaceuticals market is
being slowly prised open for the entry of generic versions of expensive
biotechnology drugs. Europe set the tone few years back by granting
regulatory approval to a biosimilar version of somatropin, Omnitope in
2006. Now the push has come from President Barack Obama’s
campaign promise to open the US market too gradually for biosimilars.
A legislative attempt to allow the US regulator, FDA, to permit
biosimilars fell through during the Bush administration in 2008. With
President Obama as a passionate supporter, votaries of biosimilar drugs
have unleashed an array of legislative proposals in March to give push
for the efforts to lower prices of biotech drugs.
The most notable effort has come from Senators Orrin Hatch and Charles
Schumer, representing both spectra of political opinion, who have
pitched for providing discretionary powers to FDA to allow follow on
biologicals of patented biotech drugs. In fact, their proposal which
will be a companion legislation to the path-breaking Drug Price
Competition and Patent Term Restoration Act of 1984 or popularly called
the Hatch-Waxman Act, seeks an encore. They have proposed reduction in
patent exclusivity period from 14 to 5 years. America’s top
biotech companies are strongly opposed to the new legislative
proposals. For the 1984 Act, allowed the emergence of a strong generics
pharma industry in countries like India, China and even in Europe to
challenge the might of the Big Pharma. Biotech majors fear a similar
repeat act by Asia’s biotech companies.
With President Obama’s support, most experts expect the
legislation to sail through and biosimilars would become a reality in
the US market by end of 2010.
Asia’s biogenerics players have been preparing for this
global opportunity. Now they are on the threshold of seeing the long
term plans to get a slice of the US market become a reality. However,
it will not be cake walk. Asia’s biotech companies will have
to invest heavily in improving quality and increasing manufacturing
capacities. They will also have to build their marketing muscle in the
US to make an impact in the shortest possible time. All these steps
will require enormous resources and so the companies will have to gear
for the new opportunity in the next two years.