Biocon’s subsidiary has entered into a co-development and commercialisation agreement with Mexican company Laboratorios PiSA for generic recombinant human insulin for the US market. Speaking to Bloomberg TV India, Biocon Chairperson Kiran Mazumdar Shaw said the tie-up will help tap the $2-billion US insulin market.

Can you give some details on how strategically the PiSA deal is going to work for you?

As you know insulin is a very important segment for Biocon. We are one of the largest insulin players — definitely in Asia. But we see ourselves as a global player in this space. Recombinant human insulin is a $5-billion market opportunity and the US market alone accounts $2 billion of this market share. And I think it is a very interesting market because it has a very attractive price point. We believe we can garner a very attractive share of this business and PiSA has been a long-standing partner of Biocon in insulin, where we have a very interesting partnership. It combines Biocon’s drug substance, which we supply. PiSA has a very highly US FDA-compliant drug product manufacturing facility, which manufactures vials and cartridges. And, therefore, we believe that this combination can be extended given the proximity that PiSA has to the US market as well as with Mexico’s NAFTA (North American Free Trade Agreement) membership, which will actually auger well for this particular opportunity.

So PiSA will only be playing the role of a manufacturer? And this tie-up is only for one product, RH insulin?

Yes, that’s correct. In fact, PiSA does market our insulin Glargine in Mexico. So this particular agreement is for the US market opportunity for recombinant human insulin. And as you know, we already have a very dominant market share of Glargine in Mexico through PiSA.

By when do you intend to start working on RH insulin and how long will it take for the filing process?

Well, it is going to take us at least two years before we can enter the US market. So the whole process is going to take us a minimum of two years to basically develop and file.

How is the business looking like at the end of Q4?

Obviously this is not a time when I should comment on Q4 results. But all I can say is that we are in a good shape for the next year. I think we have a good market opportunity given the number of filings we are going to submit for our bio-similar products in the next fiscal.

And I think we have a very interesting prospect coming up over the next year and onwards.

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