BENGALURU: The decision by the US FDA to label Biocon’s insulin glargine as an interchangeable biosimilar is a momentous decision which will help Biocon Biologics to gain market share in the country by competing with Big Pharma, executive chairperson Kiran Mazumdar-Shaw said.
“It is a game changing event and the one-year exclusivity is a huge deal for us,” she said in an interaction with TOI. “Competing with Big Pharma for trying to penetrate the US market is tough, but phar macy-level substitution becomes an easy way to compete. If you have to compete on prescription drugs or prescriber behaviour, then it will be difficult to get market share,” she said.
An interchangeable biosimilar is one where the biosimilar has high levels of comparability with the original drug - in this case a drug called Lantus. With the current decision by the US drug regulator, a pharmacy will have the option to provide Semglee - Biocon’s insulin glargine - to a customer if it does not have the prescribed drug of a doctor. Before this, a pharmacy could not sell Semglee unless it was specifically mentioned in the prescription.
This is the first interchangeable biosimilar approved by the US. And the exclusivity right means the FDA will not approve another biosimilar interchangeable to Lantus for 12 months. Based on reported sales in 2020, insulin glargine had sales of $4.2 billion globally, of which about $1.9 billion was in the US alone. “The attention has always been on the US market and how you succeed. Penetration there has always been the barometer on how strong your biosimilar business is. Even if you get higher sales outside, analysts will track you in the US,” Mazumdar-Shaw said.
While insulin glargine was approved in the US last year, two other products, rH-insulin and insulin aspart, are in advanced stages of clinical development, and the company is waiting for an USFDA inspection, which is expected to be completed this year.
