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videos | IST

Biocon gets US FDA’s interchangeability nod for Semglee; co optimistic about insulin portfolio

The United States Food and Drug Administration (US FDA) has approved interchangeability status for Mylan-Biocon's Insulin Glargine drug 'Semglee', which is used to treat diabetes. This means that Semglee can now be substituted for the reference product at any pharmacy.

The United States Food and Drug Administration (US FDA) has approved interchangeability status for Mylan-Biocon's Insulin Glargine drug 'Semglee', which is used to treat diabetes. This means that Semglee can now be substituted for the reference product at any pharmacy.
Kiran Mazumdar Shaw, executive chairperson of Biocon, on Thursday, said that it’s a big opportunity for the company and she is optimistic about the insulin portfolio.
Speaking in an interview with CNBC-TV18, Mazumdar said, “It’s a huge milestone and a big deal for us because, for a product like Insulin Glargine, it has always been very difficult to compete with big pharma.”
“Interchangeability basically allows pharmacy level substitution and with the one-year exclusivity, it puts us in a unique and special place to take advantage of being the first in the world. Therefore, I feel this is a big opportunity for Biocon to start looking at our insulin portfolio with a lot of optimism,” she said.
She further explained that insulin is not a product play for every company as it is a volume play and requires a very different supply chain.
On growth, Mazumdar said, “Double-digit growth is something that we will aspire for and as high as close to what the market is estimating, but I do not want to speculate on the target number, but it suffices to say that I do not think we need to now worry about struggling with low-single-digit growth. So that’s the opportunity it provides us with and we have to be very aggressive given the one-year exclusivity.”
On the $1 billion targets, Mazumdar said that the company is revisiting the target date as it might be difficult to get there in FY22 itself.
For the entire management interview, watch the video