Biocon Limited is now all set to make a mark in the biologics and biosimilar market. Beginning from its oral insulin programme IN105 expected to complete the patient enrolment in Q3 this year, the company will be ready with the data by the end of Q1, 2011.

In its CD6 and T1h project which covers two auto immune diseases: psoriasis and rheumatoid arthritis, the company is ready to conduct the human studies. While the trials for psoriasis will take off by the end of this year, RA will be held next year.

The business opportunity for biologics in the US is estimated at $60 billion. In the European Union it is valued at US$ 30 billion and Rest Of the World (ROW) markets is US$ 5 billion. By 2016, US$ 25 billion value of drugs will lose patent opportunity. At least seven of the top selling drugs will be biologics in 2014.

The opportunities are immense and we have chosen the right partners from Mylan to Amylin Pharmaceuticals and IATRICa, Inc. These associations will give us a good foot print into the international market, Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited said.

The partnerships are based on complementary capabilities and shared costs and we expect the paybacks to commence within three years starting with the emerging markets. Much of the returns are expected when the regulated markets open up.

The oral insulin has a blockbuster profile along with CD6 and T1h. The leading players globally are Mylan, Teva, Lonza and Sandoz in the biosimilar space, she added.

The business opportunity for the psoriasis drug market is US$ 15 billion. We will be the first company in the world to develop the drug for psoriasis. This is a segment which has large global implications and our early studies have made a huge difference to the patients, said Shaw.