Monday, 27 May 2019

Biocon gets European nod for its insulin to market globally

28 March 2018 | News

Biocon and Mylan received approval from the European Commission and the Australian regulatory body for marketing biosimilar insulin glargine globally

Indian biotech major Biocon said that the biosimilar insulin glargine co-developed with US drug major partner Mylan received approval from the European Commission and the Australian regulatory body for marketing it globally.

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.

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