Biocon Limited, a global biopharmaceuticals company known for its innovative approach, has achieved a significant milestone by receiving approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. for its complex formulation Liraglutide (6mg/ml solution for injection in pre-filled pen). This approval, obtained through its European partner Zentiva, marks Biocon as the first generics company to secure approval for Liraglutide in a major regulated market.
Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus, a condition characterized by high blood sugar levels due to inadequate insulin production or response. The approval of Liraglutide underscores Biocon’s commitment to delivering innovative solutions for complex diseases.
Siddharth Mittal, Chief Executive Officer and Managing Director of Biocon Ltd, expressed his enthusiasm for the approval, stating, “The approval of Liraglutide, a vertically integrated product, is an important milestone for us. Being the first generic Liraglutide approved in a major regulated market strengthens our leadership in delivering many ‘firsts’ on complex drug products. Our efforts will now be directed towards commercializing this asset expeditiously in the U.K., in partnership with Zentiva.”
Steffen Saltofte, CEO of Zentiva, also commented on the partnership with Biocon, saying, “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.”
The approval of Liraglutide opens up new opportunities for Biocon and Zentiva in the U.K. market. According to IQVIA MAT Q4 2023, the total addressable market opportunity for GLP-1 in diabetes and weight loss in the U.K. was estimated to be US $425 million. This approval not only expands Biocon’s product portfolio but also strengthens its position in the generics market.
Biocon’s success with Liraglutide underscores its commitment to innovation and providing affordable healthcare solutions. With this approval, Biocon and Zentiva are poised to make a significant impact on the treatment of Type 2 Diabetes Mellitus in the U.K., offering patients access to high-quality and cost-effective medications.
