Biocon readies for US, Europe off patent mart

India's largest biotechnology company Biocon is planning to tap the potential of biosimilars (generics or copycat versions of biotech drugs going off patent) in the regulated markets of the US and Europe, besides taking Insugen, its own version of insulin, to the global markets in a big way.

The company will soon launch two of its new generic versions of biotech molecules, G-CSF (granulocyte colony stimulating factor, which stimulates the bone marrow to produce more white blood cells) and streptokinase (a cardiac drug used against clotting of blood) in the domestic market.

The launch of biosimilars in the US and Europe is planned over the next two to three years, by which time proper laws would evolve for biosimilars in these regions.  Biocon is in the process of registering with the regulatory authorities in the developed markets for the launch of Insugen.

This insulin product has a 3.33 per cent share in the domestic market that is estimated at Rs 400 crore (ORG-IMS figures for August 2006 to August 2007).  Insugen has already been licensed to a US company for the US market and to Bayer for China.

Biocon chairman and managing director Kiran Majumdar Shaw said that the strategy would be to outlicense the products to different partners for different geographies and to launch on its own in Europe and other key markets.

A few weeks ago, Habil Khorakiwala, chairman, Wockhardt, had said that his company planned to launch Wosulin, its insulin version, in the US and European markets.

Majumdar Shaw said Biocon hoped to commercialise its new molecule under development for psoriasis and rheumatoid arthritis in three to four years.

The drug is undergoing Phase II clinical trials (the study on effects of the drug in a limited group of patients) in India.  Biocon is also developing an oral insulin, now in the first stage.

Biocon's Biomab, the monoclonal antibody for the treatment of cancer, will also be launched in the European market (where it is awaiting approvals) within a year.

Majumdar Shaw said the company was evaluating its options to acquire pharmaceutical and biotech companies in the US and European markets and to invest in upcoming biotech companies focussed on drug research, as part of its aggressive global plans.

"We are assessing a few drug companies in the US and Europe with front-end marketing and distribution capabilities, to take our products to the global markets," Majumdar Shaw said. "Biocon will also invest in small biotech companies having promising molecules."

Biocon plans to re-invest in acquisitions, most of the Rs 467 crore (Rs 4.67 billion) it earned from the divestment of its three-decade-old enzyme business to Novozymes A of Denmark recently.