MAJOR PLAYERS IN INDIA'S BIOGENERICS INDUSTRY
Table 1. Biotherapeutics in India and their manufacturers
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India's biogenerics industry remains relatively small, and nearly all of the products marketed now or in the near future are
accounted for by a handful of companies (Tables 1 and 2). There are four main players.
Table 2. Top biotech organizations in india by revenue
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Biocon: India's first and largest biotech company was founded in 1978. Bangalore-based Biocon is now the largest biotech firm in Asia
by market capitalization and the sixteenth largest worldwide. Biocon's existing biogenerics product line includes recombinant
human insulin (Insugen), EPO (Erypro), G-CSF, and streptokinase. Most of Biocon's pipeline is now filled with innovative molecules,
and it already markets a novel biologic, an anti-epidermal growth factor receptor (EGFR) MAb (BioMAB-EGFR) for head and neck
cancers. As Biocon's CEO, Kiran Mazumdar-Shaw, told Fortune a year ago, "Unfortunately, [analysts] still tend to categorize us as a generics company...We keep saying, 'Look, we're not
interested in generic companies, because we're trying not to be one.'"4
Dr. Reddy's Laboratories: India's third largest pharmaceuticals company, Dr. Reddy's was founded in 1984 in Hyderabad as a bulk pharmaceuticals manufacturer
and soon grew to become one of India's best known generics makers. Among other ventures, Dr. Reddy's has manufacturing plants
in the UK and a research facility in the US. The company currently markets only two biologics, both generics: Reditux, a version
of Roche's blockbuster rituximab monoclonal against non-Hodgkins lymphoma; and Grafeel, a version of G-CSF. Dr. Reddy's announced
in mid-2007 that it planned to invest $20 million to expand its biogenerics capability, and expected to roll out one new biogeneric
product per year for the next eight years.5
Ranbaxy Laboratories/Zenotech: Founded in 1961, Haryana-based Ranbaxy is India's largest pharmaceutical company. It recently decided to move toward biogenerics
by taking a large stake in Hyderabad-based Zenotech, an established biotech firm. The two companies now sell biogeneric versions
of G-CSF and GM-CSF and have an Interleukin-2 generic, a recombinant HGH generic and a rituximab generic in clinical trials.
Shantha Biotechnics: Hyderabad-based Shantha, now 60% owned by Merieux Alliance, currently markets three biogenerics—an interferon alpha-2b, a
streptokinase, and an EPO. The company's biogenerics pipeline includes a tPA product and a pegylated interferon for treating
hepatitis C, although most of Shantha's research and development has been focused on new biologics and vaccines. Shantha has
been making a recombinant-protein hepatitis-B vaccine since 1997.
Wockhardt: Based in Mumbai, Wockhardt currently has six biogenerics on the market in India: an EPO and a recombinant human insulin.
Its pipeline includes an insulin glargine generic, interferon alpha 2b, and G-CSF.
REGULATORY ISSUES
New regulatory guidelines enable a streamlined clinical trials and review process under a single National Biotechnology Regulatory
Authority.6 However, India's biogenerics manufacturers are less interested in India's market, or in other loosely regulated markets
where consumers are relatively poor, than they are in the wealthy US and European markets.
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