Biocon shares gain over 3% on UK MHRA approval for diabetes drug Liraglutide

In a filing to the stock exchanges, Biocon said that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has given its approval to the company’s complex formulation Liraglutide, which is a 6mg/ml solution for injection in pre-filled pen.

The drug’s filing was done in the MHRA by the company’s European partner, Zentiva.

The drug Liraglutide is used in the treatment of Type 2 Diabetes Mellitus. It is a disorder in which the body does not produce enough insulin, or respond normally to the one produced, leading to an abnormally high jump in the levels of blood sugar or glucose.

With this approval from UK MHRA Biocon has become the first generics company to receive a green signal for a diabetes drug.

The Chief Executive Officer and Managing Director of Biocon, Siddharth Mittal has stated that the approval of Liraglutide is an important milestone for the company, as being the first generic Liraglutide approved in a major regulated or ICH market.

This development bolsters Biocon’s leadership in the delivery of complex drug products like bTrastuzumab, bPegfilgrastim, and the first interchangeable biosimilar Insulin Glargine, which was given an approval by the United States Food and Drug Administration (USFDA).

As per IQVIA MAT data for the fourth quarter of 2023, the total addressable market opportunity for GLP-1 in diabetes as well as weight loss in the UK stood at $425 million.

“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 UK, in partnership with Zentiva,” Mittal said in a press release dated March 27.

Shares of Biocon Ltd were trading 3.6% higher at ₹266 apiece on the NSE at 1:15 pm.