Biocon and Mylan are upbeat on cancer drug trastuzumab, which has a $7-billion market worldwide. The two companies announced the presentation of data from the HERITAGE study at the 2016 American Society of Clinical Oncology Annual Meeting in Chicago, June 3-7. The study confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison with branded trastuzumab. Positive test results will enable regulatory submission for commercial launches. Speaking to Bloomberg TV India , Biocon CMD Kiran Mazumdar-Shaw says Biocon expects to market the cancer drug by 2018-19, she said.

What opportunity does this drug present to you?

This is a very important presentation by Mylan and Biocon for our first biosimilar trastuzumab. And the fact that we have such good data puts us in a very good position for approval of this particular product. So we will be submitting the dossier for marketing authorisation to both US FDA and EMA. Considering the fact that we are the first to report this positive data — compared with other companies which are also developing this asset, but are slightly behind — it is a very important announcement to make. We think that this is also a case of validating our biosimilar pipeline.

What kind of opportunity do you see for this drug?

This particular product trastuzumab, which is otherwise known as under the brand name of Herceptin, commands a market size of close to $7 billion. We expect to be in the market by 2018-19.

How long does it take between final approvals and product release?

We will be submitting our dossiers for marketing authorisation very soon. It takes about 12-18 months for the review process and thereafter we get the marketing authorisation. We should be ready to enter the market soon after that.

What is your financial agreement with Mylan?

We have a profit-sharing arrangement with Mylan. That is what will see us earning pretty large revenues from this particular time frame that I mentioned.

Can you shed some colour on the competitive landscape as far as this cancer drug is concerned? What kind of opportunity are you looking at?

Mylan is the one which is going to pursue the commercial opportunity. We expect they will try and garner as much of the market as they can.

It is difficult at this point in time to really talk about market share in real terms.

But suffice to say, it is a large opportunity and given the fact that these are very expensive drugs and discounting can actually lead to good payer acceptance, the market size could be quite attractive for both companies.

How many filings are you looking with Mylan in FY17?

We are looking at four filings. As already mentioned, we are going to file pegfilgrastim, trastuzumab, insulin glargine, and adalimumab this year.

What is Biocon’s product pipeline for FY17?

These are regulatory filings. These are not necessarily products that get into the market in FY17. But just the fact that you do these regulatory filings in FY17 alone is actually a big milestone for us because this gives you a perspective on the kind of market we are going to address in the next few years.

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