The company had filed the application for Liraglutide through its European partner, Zentiva.

Liraglutide is a drug-device combination formulation used in the treatment of Type-2 Diabetes Mellitus, a disorder in which the body does not produce enough or respond normally to insulin, causing blood sugar (glucose) levels to be abnormally high.

According to IQVIA MAT Q4 2023 the total addressable market opportunity for GLP-1 in diabetes and weight loss in U.K. was US $425 million.

Siddharth Mittal, chief executive officer and managing director, Biocon, said: “The approval of Liraglutide, a vertically integrated product, is an important milestone for us.

Being the first generic Liraglutide approved in a major regulated/ICH market, it strengthens our leadership in delivering many ‘firsts’ on complex drug products such as bTrastuzumab, bPegfilgrastim, and the first interchangeable biosimilar Insulin Glargine, approved by the U.S. FDA.

The approval is also testament to the Company’s strong focus on GLPs and peptides as important future growth drivers for the generics business. Our efforts will now be directed towards commercializing this asset expeditiously in the U.K., in partnership with Zentiva.”

Biocon is an innovation led global biopharmaceuticals company, engaged in the production of therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

The company had reported consolidated net profit of Rs 660 crore in Q3 FY24 as compared with net loss of Rs 41.8 crore posted in Q3 FY23. Revenue from operations jumped 34.43% year on year (YoY) to Rs 3,953.7 crore in the quarter ended 31 December 2023.