Tie-up with Fujifilm Kyowa to accelerate entry in European market: Kiran Mazumdar Shaw

Talking to ET Now, Kiran Mazumdar Shaw, Chairperson & MD, Biocon, says Biocon and Mylan wanted to be present in Europe during the time of market formation in biosimilars and that’s why they tied up with Fujifilm Kyowa Kirin Biologics.

Edited excerpts:

Why did you and Mylan tie up with Fujifilm instead of launching it by yourself? Is this simply a quicker approval?

Perhaps you are aware that there are already a few biosimilar players who have got approval for the European market ahead of us. It was very evident that we need to be in the market at the time of market formation which is later in this year.

The only way to basically accelerate our entry into the European market was to do this particular deal with Fujifilm Kyowa Kirin Biologics who actually had their product under advanced review and were expecting approval fairly soon. We felt that this was the only way we could actually participate in the market at the time of market formation because any other approach would have delayed our entry into the market. We are very strong as biosimilar players and it was not in our interest to delay our entry into the European market.

What is the size of this opportunity and with the third player, do dynamics of revenue and profit sharing change now?

This is a very large market opportunity. In Europe itself, this is almost a $4.5 billion opportunity and there are going to be only about three or maximum four players at the time of market formation. Therefore, we believe that this is a very important opportunity for two partners and that is why we agreed for Mylan to go ahead and do this commercial marketing deal with FKB.

What is the approximate approval time and when do you think the drug actually will be launched?

The approval is expected in the second half of calendar year 2018 and the market actually opens up by the end of the year. So, that is what we really sort of addressing.

Will similar agreements be looked into the future as well?

It is too early to say. It all depends on patent expiry dates. It also depends on your review cycles. There are a lot of moving parts in the biosimilars strategy. So, you can see that in Trastuzumab we were the first to get approval by USFDA and that is because we had a very early review.

But there are other programmes where we have to look at the competitive landscape. It all depends on the market entry strategy. It is very difficult for me at this point to even say whether this will be an approach that we will take. But regardless of that, this is such a large opportunity. Every day you are not in the market is a loss of revenue and profits for both partners. Therefore, we thought that this is the best approach.

The financial modelling that we did based on this particular licensing deal is good for both the partners.