Bengaluru: Indian biotech major Biocon on Wednesday said the biosimilar insulin glargine it co-developed with US drug major partner Mylan received approval from the European Commission and the Australian regulatory body for marketing it globally.
"Our co-developed insulin glargine Semglee has received marketing approval of the European Commission on the recommendation of the committee for medicinal products for human use of the European Medicines Agency," said the city-based pharma company here.
The Australian regulatory body Therapeutic Goods Administration (TGA) also approved the insulin in a pre-filled pen for diabetics in that country.
The Pennsylvania headquartered Mylan is an American global generic and specialty pharma firm registered in the Netherlands, with a presence at Hatfield in Britain's Hertfordshire county.
"The approval of EC and TGA are a milestone in our collaboration as it furthers our mission to provide a quality and affordable insulin analog for the people with diabetes globally," Biocon Chief Executive Arun Chandavarkar said on the occasion.
As a global insulin player, Biocon addresses healthcare challenges associated with diabetes by investing in research and development and manufacturing to build scale and make the drug affordable in many markets.
"The EC approval applies to all 28 European Union member states and the European Economic Area member states of Norway, Iceland and Liechtenstein," added the statement.