EMA accepts marketing application of Biocon, Mylan insulin glargine

New Delhi : Biotechnology major Biocon said the European Medicines Agency (EMA) has accepted its request for review of its partner Mylan's marketing authorisation application (MAA) for insulin glargine used to treat adults with type 2 diabetes.

Mylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients, who are often facing significant expense to manage their disease, Biocon said in a regulatory filing.

"The acceptance of our regulatory submission for insulin glargine in Europe is yet another example of the strong progress we continue to make across the exciting portfolio of complex products we have in development, and is another demonstration of the success of our partnership with Biocon," Mylan President Rajiv Malik said.

There is a significant unmet need around the world for more affordable versions of injectable insulin products, he added.

"We look forward to helping serve this patient population, building on our existing strength in oral diabetic drugs, by bringing this product to the European market and other markets around the world upon approval," Malik said.

Biocon CEO and Joint MD Arun Chandavarkar said the acceptance of the insulin glargine application for review by EMA is another important milestone in Biocon's collaboration with Mylan.

"This is the third filing from our portfolio comprising bio similar monoclonal antibodies, insulin analogs and other recombinant proteins to be accepted by EMA in 2016. Importantly, this is the first filing in a developed market," he added.

Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Glargine is one of the three insulin analogs being co-developed by Mylan and Biocon for the global marketplace.

Mylan has exclusive commercialisation rights for insulin glargine in the US, Canada, Australia, New Zealand, the European Union and European Free Trade Association countries.

Biocon has exclusive rights for Japan and a few emerging markets and co-exclusive commercialisation rights with Mylan in the rest of the world.