Realisations from insulin biosimilar to start from FY17: Biocon

Biocon's biosimilar insulin Glargine has received regulatory approval in Japan, where the company will be partnering with FUJIFILM Pharma.Speaking to CNBC-TV18, Kiran Mazumdar Shaw, Chairperson and Managing Director of Biocon, says, "This is the first biosimilar that would enter Japan from any non multinational company (MNC)." In addition, Japan makes for an interesting market as only three players have this product currently.Shaw is of the view that Glargine offers business worth USD 8-10 billion and realisations from the approval will start kicking in from FY17.The Japan deal will help the company enter other developed markets, says Shaw.Furthermore, Biocon will be submitting four important drug filings soon, adds Shaw.Below is the transcript of Kiran Mazumdar Shaw’s interview with CNBC-TV18's Latha Venkatesh and Anuj Singhal.Latha: How significant is this approval, does this open up a fairly big market for Biocon?A: This is a huge milestone because this is our first regulatory approval in a developed market and that too in a market like Japan which is a very difficult market to enter not only with sort of generics but biosimilars. This is the first biosimilar that would enter Japan from any non multinational company (MNC) because the first biosimilar Insulin Glargine that was approved in Japan was that of Eli Lilly and we are actually the first company thereafter to get this approval.We have partnered with a Japanese pharma company FUJIFILM Pharmaceuticals which is actually a key pharma company in Japan and this news is significant because not only is the Japanese market a pretty big Glargine market because in terms of size it is about USD 145 million but also because there will only be three players at this stage and that is what makes it an interesting market for us.Apart from that it opens up almost every market in the world. Of course what this news also means is that our filings that we are going to submit in the very near future both for US and European regulatory approval will no longer be a question mark. This means that we will enter those market sooner than later because this endorses the quality of the product and the quality of the dossier and because of the Japanese approval we believe we can enter almost any ROW market. So, this announcement is huge for us.Anuj: So you said markets as of USD 150 million. How much do you think it will be able to add to your revenues say, in a period of two years or so?A: FUJIFILM Pharmaceuticals certainly has plans to garner as much as it can of this Japanese market and that of course obviously benefits us as its partner. So, I will only give you actual numbers once we get into the market and maybe as you say two years down the line you will be able to assess the impact of Japanese market on our business but as I mentioned earlier it is not just about the Japanese market which is sizeable but it will also open up all the markets in the developing world and certainly once we get into the US and European markets you know that Glargine business itself is an USD 8-10 billion market opportunity which is the addressable market and we think we will be very significant players in this Glargine business. We see ourselves as being a very major Insulin player in the years ahead.Latha: By when before you start making money, from getting the approval to actual commercial production and making money, is it FY17 itself?A: Yes, absolutely. First and foremost we are already making good money with our Insulins. We already have our Insulins in about 60 different markets in the world. Of course some of these significant markets are about four or five. We already have Glargine in some key markets and now we believe with this approval we will have Glargine in many more markets. Insulin is almost approaching USD 100 million business as we speak but it will be a much bigger opportunity as we go forward. So, I am very excited about making inroads into all these markets and we believe that this is a significant regulatory approval that will only enable us to exponentially grow our insulin and insulin analogue business in the years to come. And as you know we have already built the scale that is required to get us there because we are both India and Malaysia to support all these businesses.Latha: Have you already filed in UK or US, should we hear approvals fairly quickly say, month or two or a quarter?A: We have already announced that in the coming year we will be submitting four important filings of our biosimilars, one of which is Glargine and we expect Insulin Glargine to be filed in the early part of next fiscal. So, we are very well set and well placed to ensure that we become significant players in the whole insulin space and that is where we see ourselves being very strong. We made the necessary investments both in terms of manufacturing and development and this program is a testimony to the quality of products and the dossiers that we are producing.A: We have already announced that in the coming year we will be submitting four important filings of our biosimilars, one of which is Glargine and we expect Insulin Glargine to be filed in the early part of next fiscal. So, we are very well set and well placed to ensure that we become significant players in the whole insulin space and that is where we see ourselves being very strong. We made the necessary investments both in terms of manufacturing and development and this program is a testimony to the quality of products and the dossiers that we are producing.