Biocon Ltd, India's leading biotech drug company is all set to tap the US biogenerics market. The US government's new affordable healthcare strategy which clears the way for biogenerics is viewed by the company as one of the lucrative business opportunities for this fiscal. .

"We see the US regulations for biogenerics to be enforced shortly. The decision on the Hatchman-Wax Act which calls for a five-year data exclusivity to the innovator is under discussion. Not only that, there are several bio-similar antibodies which are coming off patent that will offer continuous market opportunity. These are expected to usher in a new era for bio-therapeutics," stated Kiran Mazumdar-Shaw, chairman and managing director, Biocon.

In the wake of global economic slowdown which has hardly impacted pharma-biotech industry, there are huge concerns on healthcare costs which would benefit the drug manufacturing sector. Now as the biogenerics market gains momentum, Biocon has its infrastructure in place. "Production of bio therapeutics requires high technology and is different from small molecules. We are rapidly developing a robust pipeline and getting ready to face the challenging environment," she added.

The company's development plan for regulatory acceptance by EMEA and USFDA for recombinant insulin is on track. Insulin analogue Glargine is under production. It has received the Drugs Control General of India consent for marketing in India and be launched by May end and is also set for global registrations. In Germany through AxiCorp, it already has created a diabetes franchise and will be driven with biogenerics, recombinant human insulin and insulin, Glargine, in the coming years.

Biocon will invest in research and development as its future growth strategy. The company is transforming to a full fledged bio formulation major and is front ending its API expertise by looking at high growth, profitability and sustainability. For fiscal 2009-10, the company is investing Rs 100 crore. Its future prospects will be driven by R&D in both biogenerics and novel biologics programme which call for incremental investments which are expected to realize significant returns, stated Shaw.

Its healthcare sales have grown with six key brands in oncology, nephrology, diabetology and cardiovascular and are in the top 10 ranking in the domestic market, according to IMS data. The drugs included Insugen, Erythrosafe, Metadose (metformin) BioMabEFGR, Myconaise, Olystat for obesity, Telemystan a once day hypertension, stated Rakesh Bamzai, president, marketing, Biocon.

The company is looking a 10 per cent increase in manpower and will hire around 400 personnel this year in R&D and sales.