Biocon obtains approval for diabetes drug Liraglutide in UK

Bengaluru: Biocon Limited, a global biopharmaceuticals company, has announced that the Company has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K., 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 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.”