Dr Reddy’s Laboratories Ltd. on Thursday, November 5, said Brazil’s drug regulator has granted marketing authorization for a generic semaglutide injection.
The company, in an exchange filing, said it received the market authoritisation from Brazil’s National Health Surveillance Agency (ANVISA) for the generic semaglutide injection along with its subsidiaries.
The semaglutide injection is used for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, either as monotherapy when metformin is considered appropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes.
The product will be available as a pre-filled, multi-dose injectable pen in two presentations – 2mg/1.5ml and 4mg/3ml – for once-a-week dosing, the company said.
Dr. Reddy’s Laboratories stated that Brazil has 16.6 million adults in the 20 to 79 years range living with diabetes and the country globally ranks sixth in terms of adults living with diabetes. It added that the semaglutide market for diabetes is estimated at approximately $244.6 million.
MV Ramana, CEO, Global Generics, Dr Reddy’s Laboratories, said the company plans to launch semaglutide in Brazile with Aché. Ramana said the approval builds on the company’s broader semaglutide strategy and brings it another step closer to making the drug available to more patints.
“Our focus with semaglutide is to expand access to this treatment option across makets where the patient need is significant. Brazil, with its substantial burden of diabetes, is an important part of that journey,” Ramana added.
Shares of Dr. Reddy’s Laboratories recovered from the lows of the day after the announcement and are now trading above the flat line at ₹1,376.4. The stock has gained 10% so far this year.
Also Read: Bombay Coated & Special Steels shares list at 12% premium over IPO price