Biotechs weathering the storm
weathering the storm
are looking up for the few dozen global biotech companies, including
some of India’s leading players, who have invested heavily to
make biosimilar drugs. The world’s biggest
market, the US, is taking some tentative steps to keep the
open for biosimilar drugs. A new legislation introduced on March 26 in
the US senate, with support from both the Republican and Democratic
party, seeks to make things easy for the entry of biosimilar versions
of expensive, patented biotechnology-based drugs.
The legislation proposes to provide discretionary
to the US regulatory, the Food and Drugs Administration (FDA), to
approve biosimilar products. Europe had allowed selective entry
of biosimilars a few years ago and policy makers, opinion
and healthcare activists have been campaigning relentlessly for the
entry of biosimilar for some time now to increase affordability of many
of the life-enhancing drugs made through the biotechnological route.
During his campaign phase, US President Barack Obama had stressed the
need to lower medical costs and his administration is likely to
override objections of the Big Pharma against biosimilar drugs.
A significant number of Indian biotechnology
have been preparing for the much-awaited support to biosimilars in the
world’s largest market and many business plans were based on
a scenario. All these companies can now wait for the golden
opportunity. In fact, companies like Biocon, Serum Institute, Shantha
Biotech, Bharat Biotech, Panacea Biotec and new entrants like Lupin,
Glenmark could benefit immensely in the long run by the imminent
opening of the doors for biosimilars in the US market.
Shantha has started work on a new manufacturing facility for
biologicals. Serum too is ramping up the capacity. Biocon has just
completed an expansion project. Many pharma companies have dusted up
their biotech plans. Dr Reddy’s has introduced two biotech
products and is working on at least eight more biosimilars.
Wockhardt’s biotech unit is up for grabs as the company tries
reduce its debt burden and at least two global majors are eying this
While biosimilar scene is hotting up, Bangalore-based
Group company, Stempeutics, has got the regulatory approval to start
clinical trials of a stem cell based drug to treat cardiovascular
And the biotech crop scenario is also looking up
India moving up the ladder to become the world’s fourth
grower of biotech crops. This is happening even as the opponents of
biotech crops are upping the ante to stall the entry of the
country’s first biotech food crop, a Bt brinjal variety.
The year 2008 had been a year of robust growth for biotech crops
according to the latest report released by the International Service
for the Acquisition of Agri-biotech Applications (ISAAA). From six
countries growing biotech crops in 1996, today the number is 25 and
more and more developing nations are adopting transgenic crops. In
2008, the global hectarage of biotech crops reached 125 million
hectares, up from 114.3 million hectares in 2007, which is
million more hectares (the sixth largest increase in 13 years) .
The year also saw the planting of the second-billionth acre (800
millionth hectare) of a biotech crop – only three years after
first one-billionth acre of a biotech crop was planted in 2005 which
took 10 years. In 2008, two-thirds of the 25-biotech countries planted
biotech maize, 10 biotech soybean, 10 biotech cotton, and three
countries planted biotech canola. Over 13.3 million farmers benefited
from Bt crops.
According to the report, the future surely belongs to Bt crops with
more than 40 countries expected to adopt biotech crops, with 15 or more
new countries projected to plant biotech crops for the first time
The results of a consumer survey conducted by the Asian Food
Information Center (AFIC) indicated that Indian consumers are
ready to embrace biotech foods. This is good news for farmers
intend to grow Bt brinjal, Bt rice, and other transgenic food crops
when the regulatory clearances are given.
Bt rice could be launched in India by 2011–12 according to
ISAAA report. Rice is the second most consumed cereal grain, after
maize, for a large part of the world’s population and Bt rice
almost ready for adoption (pest/disease resistant biotech rice) in
China. With over 43 million hectares, India has the largest rice
acreage in the world and is the second largest producer of rice with
production at 96.43 million tonnes in 2007-08. Things are indeed
up for the biotech sector.