Eric Langer
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India's pharmaceutical manufacturers currently sell close to 30% of the world's generic therapeutics. Sales of generic versions
of biologicals in India have grown rapidly, and that growth will likely expand into export sales over the next decade, according
to the joint study, Advances in Biopharmaceutical Technology in India, (February 2008) by BioPlan Associates, Inc., and the Society for Industrial Microbiology.
Biogenerics represent a high-growth sector in India, where recombinant insulin, granulocyte cell stimulating factor (G-CSF),
interferon alpha, erythropoietin (EPO), monoclonal antibody (MAb) products, and recombinant vaccines are manufactured by a
number of domestic biotech companies. The costs of Western-made biopharmaceutical products places them out of reach of much
of the world, and many of these products are close to losing their patent protections. To assist the Indian biotech industry
in seizing this opportunity, the Indian government has streamlined some of its drug application and review procedures, and
has offered strong tax incentives. As a result, India's biotech industry has been investing heavily in the development of
facilities. It is expected that Indian biogenerics makers will soon receive their first approvals to manufacture products
for the European market.
"Indian companies such as Biocon, Dr. Reddy's Laboratory, Intas Pharmaceuticals, MJ Biopharma, and others have the skills
to develop and manufacture recombinant biotech products," says Ashesh Kumar, PhD, head of Medipolis GMP. These products include
hepatitis B vaccine, streptokinase, human insulin, G-CSF, EPO, human growth hormone (HGH), interferon alpha-2a, and MAbs for
cancer and Hodgkin's lymphoma.
BIOLOGICS MANUFACTURING IN INDIA
Following the success of its generic pharmaceutical industry, Indian policy makers plan to repeat this in the biogeneric sector.
Indian biotech revenues, currently at about $2 billion, are projected to reach $5 billion by 2010. Already, nearly 60% of
these revenues are from exports.1 The year 2005 was an important milestone for Indian biotechnology as revenues crossed $1 billion.2
ROADBLOCKS TO BIOGENERICS DOMINANCE
The success demonstrated by India's small molecule generic drug industry may not be a easily duplicated, however, for several
reasons.
- The research infrastructure, academic network, and overall talent pool are small compared to those supporting the traditional
pharmaceuticals industry.
- There have been greater regulatory hurdles for biologics in major markets, in particular, the lack of bioequivalence laws
in the US, and the lack, until recently, in Europe.
- The costs and the technical challenges of making biogenerics are higher than for traditional chemically synthesized generics.
Yet, India seems intent on developing a world-class biotech capability. Even in the early 1980s, when Genentech and other
American biotech companies were just beginning to make headlines, the Indian government initiated a program to promote its
own biotech industry. In 1982, the National Biotechnology Board was set up under the Ministry of Science and Technology and
became the Department of Biotechnology (DBT) in 1986. The DBT now spends close to $200 million annually to develop biotech
resources in the country, including the expansion and improvement of academic programs, the development of more and better
infrastructure, the nurturing of biotech companies, and the improvement of technology transfer to businesses from universities
and other noncommercial laboratories.
This enthusiasm for biotech springs partly from an appreciation that biotherapeutics represent the future of medicine. But
Indians also see in biotech an advanced, high-tech industry more in keeping with the image they expect of their country. Immensely
proud of their world-class IT industry, Indians would like to mirror this in biotech, thus becoming "one of the nations to
be counted" in the world community.3 And a natural step is for the country to become a major producer of generic biologics.
THE OPPORTUNITY
Blockbuster first-generation biotherapeutics developed in the West are already starting to lose patent protection in Western
markets, and in the next decade, even second-generation products will begin to go off-patent. The biogenerics markets in Europe
and the US together could amount to more than $15 billion in the next three years, at an average annual growth rate of close
to 70%.
