Trastuzumab approval is a milestone: Biocon

We expect Biocon's share of profit to be significant and also expect a large contribution from biosimilars going ahead, said Mazumdar Shaw.

She expects a few more companies to eventually launch drug similar to Trastuzumab.

According to her, market for biosimilars in next five years is not expected to get overcrowded.

Below is the verbatim transcript of the interview.

Latha: Can you take us through the milestones with this US-FDA approval?

A: It is a huge milestone for us and for the country because this is the first biosimilar trastuzumab to be approved by US-FDA, which is of course a very proud milestone for us and more than anything else, it is a validation of our capabilities and our abilities to develop such a high quality complex biosimilar drug and of course there are just a handful of biosimilar players in the world and it helps us to join this league of players. I think in terms of milestones, all I can share with you is that this is a molecule that has been under development for seven years, it is a very complex programme, huge investment has gone into this obviously it was considered a very high risk reward game that we are playing and I think we had very nervous shareholders and investors who felt that maybe this is a very risky path for a company in India but I think we basically demonstrated to our investors that we can do it and I think this is a big market opportunity for Biocon and Mylan. It is USD 6 billion global opportunity, the US itself has a USD 2.5 billion market at the moment, Europe has USD 1.5 billion and the rest of the world has about USD 2 billion in growing and this is a product that is very lifesaving product and so much so that the WHO has included this in its essential medicines list. So I think the prospects for growth, the prospects for Biocon and Mylan to provide affordable access to this very important drug is huge.

Anuj: The market would want to know some numbers. You spoke about USD 6 billion overall market, in the US itself, with the kind of price erosion now and the first year market share, what could be the number that we could look at, USD 50 million, 100 million for Biocon?

A: Mylan is driving the commercial strategy for this drug in the US and obviously they would like to garner as much market share as they possibly can and we have a profit sharing arrangement with them. We believe that over the next few years, obviously if there is a ramp up time and obviously it will mean that our share of the profit is going to be pretty good because we expect Mylan to do well with this drug. So I cannot, at this point in time, share the numbers but we have indicated that over the next three years or three fiscals, we do expect large contribution from biosimilar and over the next five years, we certainly expect over a billion dollars just to come from the contribution of biosimilars and the profit share to our business.

Latha: USD 1 billion over the next two years?

A: Five years.

Sonia: What would your vision be in terms of monetising the business as a whole perhaps maybe hiving it off, looking at some kind of listing in the US, any stake sales?

A: We have created a separate entity called Biocon Biologic and we do intend to basically park all our biosimilar assets in this company and at some stage in the near future, we do expect to list it to monetise the value.

Latha: Near future would mean what? Are you looking at it within the next 12 months?

A: No, not at all. I think it would be over a sort of three-four year period.

Latha: More about the drug itself, what is the launch date and is there a settlement with Roche that is already in place?

A: Mylan has a settlement with Roche in place and that is what brings about the certainty of market entry. I am unable to disclose the actual launch date for confidentiality reasons.

Sonia: Does this also open the door for other biosimilars like Pelfilgrastim etc anything in the near future that we could look forward to?

A: Absolutely because if you remember we got a complete response letter to Pelfilgrastim and it only part of the complete response pertained to our CAPA completion and CAPA updation in our files and we have just completed the CAPA, so we expect to submit all that data and hope that approval comes within a short-term.

Latha: The eight observations in that March-April inspection was a bit rattling, now the market doesn’t have to worry about that you think?

A: I must tell you that there were two inspections, one was a pre-qualification inspection, which we thought we did very well with but what gave us a surprise was the May inspection, which had 483s which were of concern.

Those have been put to rest because we have got an EIR from US-FDA and we have got a VAI classification for the EIR which indicates that they are satisfied with the responses we have given, they are also now satisfied with the completion of the CAPA. So hopefully, that will see us in a different light.

Latha: I understand other companies like Pfizer have also filed for a drug similar to Trastuzumab, you don’t expect that – you said USD 1 billion in five years, will the market face too much of competition?

A: I talked about USD 1 billion from our biosimilars business. I didn’t just talk about one molecule but what I do want to say is that, I think we do expect a few more to be approved. I think Pfizer being one of them and they are likely to be two others. As Merck has also got the approval in Europe so we expect them to be following closely on our heels in the US but having said that, having a few players is not like the generics market, which has multiple players. We expect that for the next five years, the market for biosimilar is not going to be overly crowded. So it allows us to basically have a very good position in the market.

Sonia: Roche is also awaiting an approval for the combination of Herceptin and Perjeta in breast cancer, if that nod comes through, could that limit the penetration in biosimilars?

A: I don’t believe so because I think there is a huge market for Herceptin on its own.

Latha: Now I guess the approval from the European drug regulator won’t be such a big problem, what is the size of the European market?

A: One and a half billion at the moment and I do believe that with biosimilars coming in this market will only expand. Also I think you have heard that our dossier was expecting for review by EMA when we resubmitted the dossier and they have clearly told us that they are reviewing it and the re-inspection will also take place and we hope to get approval soon after.

Latha: You have around 6-8 drugs in line with Mylan for biosimilars, don’t you?

A: That is right.

Latha: What are the others in the pipeline and any timetable at all for their getting approval and coming to the market?

A: Glargine is also being reviewed by both US-FDA and EMA at the moment. We have a bevacizumab under phase III trial and we have other products in the pre-clinical stage, which we expect to get into the clinic very fast.

Latha: So we are looking at what a year’s timetable for these things to start rolling out or two years, what stage are they?

A: Certainly the pegfilgrastim and trastuzumab certainly have a very near-term entry. The others will probably follow soon after.