Small players make it big with off-patent drugs

Competing with established biotech companies in India such as Wockhardt, Biocon and Reliance Life Sciences, small biotech companies such as Zenotech, BV Biocorp and Intas Biopharma are likely to emerge as major Indian players in the field of biogeneric drugs, copycat versions of off-patent biotech drugs.

The biogenerics market is expected to grow to $25 billion in Europe and $30 billion in the US by 2015 as many existing blockbuster biotech drugs are going off-patent in the coming years.

BV Biocorp, the biotech drug research arm of the Pune-based poultry major Venkateswara Hatcheries (VH) group, is close to launching three biogeneric drugs in the global markets even ahead of players such as Reliance Life Sciences.

While biogenerics of Reliance Life Science's recently acquired a UK facility, GeneMedix, Wockhardt, which has developed six biogenerics, is yet to decide on launching its product in the US market.

"Our biogenerics are in the therapeutic areas of cancer, arthritis and cardiovascular diseases. Two of the drugs are undergoing phase-III clinical trials in the US and India and the third drug will soon enter the phase-III trials. The drugs have shown excellent results so far and could be commercialised within a year," said O P Singh, chief executive officer, VH group.

BV Biocorp is also setting up three plants for drug manufacturing with an investment of Rs 43 crore at the Rajiv Gandhi Biotech Park at Hinjewadi and at the special economic zone in Pune. "We may set up two to three plants depending on the requirement or may even opt for the inorganic route to scale up the production facilities depending on the demand for products," he said.

Intas Biopharmaceuticals, another emerging player, already markets indigenously developed biopharmaceutical products such as recombinant human Granulocyte Colony Stimulating Factor (G-CSF) under the brand name of Neukine, Erythropoietin (EPO) under the brand name of Erykine and Epofit and Interrferon Alfa 2b as Intalfa in India. Six more products are in the pipeline and the company hopes to launch one to two products every year in the coming years, according to Mani Iyer, director, Intas Biopharmaceuticals.

The generic opportunity for EPO (for chemotherapy and renal failure), GCSF (prescribed to make more white blood cells during cancer treatment), Interferon Alpha (for Hepatitis C and renal failure), Interferon Beta (to treat multiple sclerosis, a chronic disease that affects central nervous system) and human insulin, together with a current market size of $7200 million, is estimated to have a market size of $7 billion alone in Europe by 2015. The European Union has already enforced guidelines for allowing biogenerics and the US is actively considering to approve marketing of biogenerics.

Zenotech, which developed its own versions of cancer drugs AGM-CSF and G-CSF, has three other biogenerics under development. The company also has developed generic rituximab, a biotech drug used to treat a type of cancer called non-Hodgkin's lymphoma. Zenotech is also developing interleukins (IL-2), used in cancer treatment to stimulate white blood cells. The company, which sold its 10 per cent stake to Ranbaxy, has teamed up with the same pharma major to market its products in the global markets.