Biocon readies EU plans for its biologicals

Bangalore-based biotechnology major Biocon is betting big on two biologicals "" insulin and GCSF "" and is gearing up to enter European regulated markets through the partnership route.

"The company plans to work with leaders in markets in Europe. We are definitely tying up with people, because we don't have marketing and sales forces and don't intend to create them in European countries," said Ajay Bharadwaj, president-marketing Biocon.

Biologicals are products containing biological material of either animal, human, plant or microbial origin and include diagnostic kits, reagents and media used in research, medical or associated fields.

The European regulatory authorities have recently spelt guidelines for four biologicals "" insulin, GCSF (a medication to stimulate production of white blood cells), HGH (human growth hormone) and EPO (erythropoietin, a hormone produced by the kidney that promotes the formation of red blood cells by the bone marrow).

"Biocon is definitely preparing itself to launch with GCSF and insulin where we are in a good level of preparedness in addressing all the guideline requirements," said Kiran Mazumdar-Shaw, chairman and managing director of Biocon Ltd.

"I think biogenerics and follow-on biologicals are extremely important for us. Insulin and GCSF in particular are the immediate opportunities," she added.

The company in the last one year has made inroads into unregulated markets with its insulin business and is now eyeing the lucrative regulated markets where European regulatory authorities have come out with draft guidelines.

Biocon, having done clinical trials for insulin in Europe on European subjects through comparative studies, is well positioned to make an early entry.

On the European statins' market, Kiran Mazumdar-Shaw said, "The prices of statins have stabilised and that is why you are even seeing there is not much of shift in the margins."

The company's EBITDA fell around 3 per cent for Q2FY06 compared to the corresponding quarter of the previous year, largely because of the price reduction in the statins business in the Europe.