To market Roche's cancer drug clone from FY14 end: Biocon

Biocon has received approval to market Roche's cancer drug clone. Roche, the Swiss innovator firm, markets Trastuzumab in India under the name Herceptin.

Kiran Mazumdar Shaw, CMD, Biocon says the nod is for India marketing rights but opens up huge opportunities as the cancer drug has a market of USD 6 billion worldwide. Biocon is developing this biosimilar in partnership with Mylan and expects to begin marketing the cancer drug clone by FY 2014-end.
Shaw insisted that the company's growth is dependent on all its verticals and insulin, small molecules and research services businesses are seeing robust growth. Below is the edited transcript of the interview on CNBC-TV18: Q: We want to speak to you about this cancer drug for which you have now got the central drug regulator’s nod. Roche also has not applied for extending its patent on that, does this open up a very big opportunity for you in terms of money? What does this mean and when can you benefit from this cancer drug?
A: I should explain this particular approval to you. What we have got the nod for India marketing rights and I think this is a very important milestone for us because it does open up many other markets or rest of the world markets because you can leverage this data and approval to market in other markets. But the main focus and target of this particular biosimilar Trastuzumab or which is otherwise known as Herceptin is Roche’s very important and high profile drug for breast cancer, which currently has a market of about USD 6 billion globally. Of course we are focusing on the US, European approvals. And as we speak, there are ongoing global trials for the same drug and the good news is that the protocol that we used in India was identical to that which is ongoing globally. We have done this trial in India in compliance with various international regulatory guidelines which seek data for safety efficacy and immunogenicity and we have met these particular non-inferiority criteria. I think that is what the big news is and that is the milestone that we are very pleased to have achieved. Q: When does it actually come to market in India and therefore is it in the FY14 profit and loss (P&L) that we will see the gains?
A: Yes, we definitely expect to market this in FY14. This is a partner drug with Mylan. So I think both partners are looking at marketing this particular drug under their respective brand names in the Indian market to begin with. Q: In terms of revenue potential or revenue gains, what kind of ballpark figures are we looking at in FY14?
A: FY14 will not have a significant impact because we will just be entering the market. The Indian market per se is expected to reach around Rs 300 crore for this drug. So we obviously expect to capture a sizeable part of this market share. Having said that, I think what is also important is that the rest of the world (ROW) markets themselves are estimated to be about a billion dollars for this drug. It is a very important drug. That is where interesting opportunities are. So I think Biocon is going to do pretty well out of this drug as is going to be Mylan and the big opportunities are post 2016 in US and Europe.