Biocon Limited, an innovation-led global biopharmaceuticals company, has announced that it has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, for its complex formulation Liraglutide (6mg/ml solution for injection in pre-filled pen), which was filed 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.

Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd. 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 USFDA. 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.”

Steffen Saltofte, CEO, Zentiva said, “The partnership with Biocon on Liraglutide reaffirms the strong position of Zentiva in the area of diabetes and is a prerequisite for entering into new therapeutic areas, such as obesity. We are proud to have obtained approval for the first Liraglutide generic, that will allow people access to the high-quality and affordable medicines they depend on.”

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