Bengaluru: The decision by the US FDA to label insulin Glagine Biocon as an exchangeable biosimilar is an important decision that will help Biocon Biologika to get market share in the country competing with Big Pharma, said Chief Executive Kiran Mazumdar-Shaw.
“This is a change event game and one year exclusivity is a big deal for us,” he said in the interaction with TOI.
“Compete with major pharmacy because it tries to penetrate the difficult US market, but the Phar Macy substitution is an easy way to compete.
If you have to compete with prescription drugs or prescriber behavior, it will be difficult to get a market share,” he said.
Biosimilar which can be exchanged is one where biosimilar has a high level of comparison with original drugs – in this case the drug called Lapus.
With the current decision by US drug regulators, the pharmacy will have an option to provide semige-biocon’s insulin glargine – to customers if they do not have a drug prescribed by a doctor.
Before this, the pharmacy could not sell semgee unless it was mentioned specifically in the recipe.
This is the first biosimilar which can be exchanged approved by the US.
And the correct exclusivity means the FDA will not approve other biosimilar which can be exchanged to Lantus for 12 months.
Based on sales reported in 2020, Glagine insulin has sales of $ 4.2 billion globally, where around $ 1.9 billion in the US only.
“Attention is always on the US market and how you succeed.
Penetration There is always a barometer about how strong your biosimilar business is.
Even if you get a higher sale outside, analysts will track you in the US,” said Mazumdar-Shaw.