Biocon, Zentiva gets Decentralized Procedure approval for generic diabetes, weight management drug in EU
Bangalore: Biocon and its European partner, Zentiva, have received a Decentralized Procedure (DCP) approval for its complex formulation, Liraglutide, in the European Union (EU).
The approval is for the generic versions of Victoza to treat Type-2 Diabetes and Saxenda used in the treatment of weight management.
According to WHO, diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn't make enough insulin. In the past 3 decades the prevalence of type 2 diabetes has risen dramatically in countries of all income levels.
Medical Dialogues team had earlier reported that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of YESINTEK, an Ustekinumab biosimilar intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease - based on the application filed by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.
Read also: Approval of Biocon Biologics Yesintek recommended by EMA Committee
Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
Read also: Biocon Chief Kiran Mazumdar-Shaw conferred Jamsetji Tata Award by Indian Society for Quality
