Biocon's Liraglutide Approved by UK MHRA for Diabetes

Biocon received approval for its complex drug-device combination Liraglutide (6mg/ml solution for injection in a pre-filled pen) from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).

Biocon's European partner, Zentiva, filed the drug used to treat type 2 diabetes Mellitus, a disorder in which the body produces insufficient insulin, causing high blood sugar (glucose). 

Siddharth Mittal, CEO and Managing Director of Biocon Ltd considers the approval of Liraglutide to be a significant milestone for the company. With this approval, Biocon strengthens its leadership in delivering "firsts" on complex drug products, such as trastuzumab, pegfilgrastim, and the first interchangeable biosimilar Insulin glargine approved by the US FDA. This approval also indicates the company's strong focus on GLPs and peptides, which are important future growth drivers for the generics business.

Biocon will focus on commercializing this asset in the UK in partnership with Zentiva. Steffen Saltofte, CEO of Zentiva, believes that the approval of the first Liraglutide generic is a prerequisite for entering new therapeutic areas, such as obesity.

The Biocon-Zentiva partnership on Liraglutide reaffirms Zentiva's strong position in diabetes and its commitment to providing high-quality, affordable medications to people who depend on them.

Finally, according to IQVIA MAT Q4 2023, the total addressable market opportunity for GLP-1 in diabetes and weight loss in the UK was USD 425 million.