Trastuzumab marketing approval may come in 12-18 months: Biocon


says that marketing approval for the drug is likely to come in next 12-18 months. The addressable market for the drug is USD 7 billion, which opens up a huge opportunity for Biocon and Mylan both.

Biocon, which had guided for 3-4 biosimilar approvals in FY17, has filed for an approval already and plans to file two more in second half of the current fiscal, Shaw says.

The biggest ramp-up for the company currently is getting approvals from Europe markets. There is visible traction in emerging markets as well, she says adding that ex-US and Europe market look attractive for the company.

Biocon’s insulin Glargine has recently received approvals from Japan and Mexico and is expected to get approvals in other markets as well.

Below is the verbatim transcript of Kiran Mazumdar Shaw’s interview to Latha Venkatesh, Sonia Shenoy and Anuj Singhal on CNBC-TV18.

Anuj: Can you tell us what is the opportunity size and how much do you think Biocon will be able to tap it?

A: This is a major milestone for the two companies because there is a high probability that we could be the first biosimilar trastuzumab to be approved for marketing by European Medicines Agency (EMA) and as you can imagine this is a very big milestone for both companies. The market size, the addressable market size, as we speak, is close to USD 7 billion for this particular drug and we believe that this is a very big opportunity for both companies.

I will not be able to give you very clear optics on exactly what the two companies expect to garner in terms of market share but it is evident that it is a large opportunity for both companies and given that the companies have a profit share in this business, Biocon will also hugely benefit from this product.

Latha: Mylan and Biocon say that the EMA has accepted for review of Mylan’s application. Does this mean that you have got permission to market? What is the distance from here to there?

A: No. The regulatory processes are fairly complex in the case of a biosimilar drug and the first sign that you are on the right path is that if they accept your dossier, it means that the file is considered to be reviewable for marketing approval.

Of course, there is no guarantee that you will receive marketing approval but the probability is that you will receive marketing authorisation considering the fact that most regulatory agencies like EMA and US-Food and Drug Administration (FDA) will look at the completeness of your dossier and if they feel that you have provided all these required information, they will start the review process. So this in our parlance is a big milestone.

Latha: Typically how long is the review process before they tell you that you have ticked the box?

A: We could see an approval as soon as one year. It is generally 12-18 months. India is generally the fastest on this particular front.

Sonia: You have indicated earlier that you are going to file three-four biosimilars in the US and in EU in FY17. Are you on track to meet that guidance?

A: We have already filed our Pegfilgrastim dossier with EMA and that indicates to you that we are on track and we expect to be able to file the remaining two later this fiscal.

Latha: Then this goes to the USA, the process?

A: Yes. We have started with EMA but we will follow it up with the submission to US-FDA, hopefully this fiscal.

Latha: Speaking of US, even today our US counterparts were cross-questioning a senator who was going to meet Mylan that this is after Hilary Clinton raised all those questions about the prices of EpiPen. The news channels were full of that. Is this now going to become a bit of a global trend and will we see some shadows being cast on India as well in terms of pricing?

A: No, basically what the EpiPen issue is about is a very steep increase in prices, which Mylan has taken and I guess that is what a lot of US pharma companies have been accused of in the recent past. Considering the fact that it is election time, I think the decibel level gets stronger on these kinds of issues.

Having said that, Mylan is preparing to face generic competition before too long and I think these are market dynamics and market practices. So I wouldn’t read too much into it at this point in time but yes, it is an issue that Mylan is addressing and I don’t think it will have a serious impact on them long-term because I think the pipeline that they have especially the biosimilar pipeline that we share with Mylan obviously offers a huge opportunity for Mylan.

Sonia: So, you told us about the market size for Trastuzumab, which is a whopping USD 7 billion. Can you just tell us for your emerging market sales as a whole whether it is Insulin, Glargine or Trastuzumab, what kind of a ramp up can we expect to see in the second half of FY17?

A: The biggest ramp up that you can expect to see is when we get European approval. That would be the biggest ramp up. In the meantime, we are seeing traction in some of the emerging markets and it is difficult for me to predict the approval timelines in many of the emerging markets. At this time we are in the Middle East and we hope to get into the Latin America but until then it is very difficult for me to forecast and predict because regulatory timelines can miss a quarter here and there. So, it is difficult for me to give you those exact figures.

However, suffice to say that we expect the ex-US, Europe markets to be very attractive and lucrative for Biocon. Glargine has been approved in Japan and it has already been approved in Mexico and we are expecting a few more approvals for Glargine in many other markets. So, between Glargine and biosimilars, we expect to see a fairly decent ramp up for the rest of this fiscal but the big ramp up is going to come starting next fiscal.

Anuj: It is tough to talk about quarter to quarter. But this Japanese opportunity and a couple of other emerging market opportunity, do you get a feeling — and this I am asking from a shareholder’s point of view — that Biocon is now at inflection point? Ever since your shareholders haven’t got much reward, the stock has been a bit of an underperformer compared to the sector but this year has been different. Do you see over the next four or five years a big compounded annual growth rate (CAGR) in earnings per share (EPS) numbers because of all these opportunities?

A: I would answer your question by saying that it is not that the stock has underperformed. It is about shareholder expectations and shareholder understandings of what our business is all about and they were refusing to accept that this business is s gestational business and this certainly is a very major inflection point for Biocon. The markets are beginning to understand what we have done in the recent past and now is absolutely a time when shareholders can expect to be rewarded in sticking with this stock.

Sonia: Just one more timeline. You did say that you expect the EMA to get back to you within one year on this filing that you have done.

A: No, we mean marketing authorisation, not get back. Review process means they will go through the dossier and they will start asking us questions on aspects of our dossier but the actual marketing authorisation is something we expect to get within 12-18 months. We also submitted a very high quality paper at American Society of Clinical Oncology (ASCO) recently which shows you how comparable our product is with the reference product.