Shreehas Tambe
CEO and Managing Director, Biocon Limited
Notable Quotes
We are the first interchangeable biosimilar as far that the FDA has approved. It is indeed a very proud moment for us.
We are not in a rush. We will do this in a responsible manner.
We have a very balanced mix. There's no exposure in any one particular market.
The opportunity ahead is far more exciting than what we've seen at Biocon Biologics so far.
We are very proud of being the first and the only interchangeable rapid-acting insulin analog in the U.S. market at this point.
The future clearly is far more exciting than what we have seen before.
The only piece that was remaining was the site GMP status. With that achieved, we've responded to them saying that we've now completed this, and we want them to reconsider our application at the earliest.
I think the Viatris settlement deal was about the deferred payment that we had to work on. And like we've said, we've been able to close out the entire $335 million.
We do not see any other biosimilar for Aspart at this point in time. We've said in the past as well that the agency has clearly given an indication that there is no outstanding question on the science or the dossier at this point in time on Aspart.
I know it can be frustrating, and it can be very, very difficult sometimes to see how these things evolve. Believe me, it's very frustrating for us as well. But we are committed to this, and we will continue to work with it to make sure that we get to that finish line sooner than later.
We do not see this market as an 8, 9, 10-player market for a long time. We expect this market to consolidate, and we expect those players which will have the ability to endure over a period of time, which requires you to be fully integrated.
We are in constant conversation with the agency, and we will provide them with whatever is required for them to assess the readiness of this site to supply new products.
Earnings Appearances
Biocon · Q2 FY26
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Biocon · Q1 FY26
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Biocon · Q4 FY25
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Biocon · Q3 FY25
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Biocon · Q2 FY25
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Biocon · Q1 FY25
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Biocon · Q3 FY24
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Biocon · Q2 FY24
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