Biocon Gets U.S. FDA Nod For Interchangeable Biosimilar Insulin For Diabetes; Shares Rise

Biocon Ltd. has received the U.S. drug regulator’s approval for its first interchangeable biosimilar insulin to treat diabetes.

Semglee will be manufactured by Biocon Biologics Ltd., a subsidiary of Biocon, and marketed by its partner Viatris Inc. (earlier Mylan Pharmaceuticals Inc.) in the U.S., where more than 3.4 crore people have been diagnosed with the disease. “Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes,” an exchange filing said.

This product can be substituted for its reference drug Lantus, an insulin-glargine manufactured by Sanofi, at pharmacies without the intervention of the prescriber, the filing said. It’s much like how generic drugs are substituted for brand name drugs. “The company [Biocon] is eligible to have exclusivity for 12 months before the U.S. Food and Drug Administration can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway.”

Biosimilars and interchangeable biosimilars have the potential to reduce healthcare costs, similar to how generic drugs have reduced costs, the filing said citing the FDA statement. Biosimilars marketed in the U.S. typically have launched with initial list prices 15-35% lower than comparative list prices of the reference products, it said.

According to Phillip Capital, Biocon, which has a 2% market share for $2.6-billion insulin-glargine (or Rs 19,304.35-crore drug) in the U.S., is estimated to have a 6% and 15% market share for a sales of $20 million (Rs 148.45 crore) and $60 million (Rs 445.49 crore) in FY22 and FY23.

The approval for interchangeability with no incremental visible competition could bring in 8%/17% incremental earnings for Biocon at 30%/50% market share, assuming a ramp up in sales and greater penetration on account of interchangeability and new launches and other markets, the brokerage said in a note.

Shares of Biocon rallied as much as 6% to Rs 404.9 apiece before paring gains. The stock has dropped around 17% so far this year compared with the benchmark Nifty 50 index’s 13% gain in 2021.

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