European regulator accepts to review Mylan’s MAA for insulin glargine

The insulin glargine, which has been co-developed by Mylan and Biocon, is used to treat adults with Type 2 diabetes and adults and paediatric patients with type 1 diabetes.

It is the companies’ third filing for biosimilar monoclonal antibodies, insulin analogs and other recombinant proteins to be accepted by EMA in 2016.

The filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy and safety global clinical trial in Type 2 diabetics patients.

The study demonstrated PK and PD bioequivalence to Sanofi's Lantus drug.

Mylan President Rajiv Malik said: “Fifteen percent of the world's pharmaceutical spend will be on diabetes medicines by 2020 and there is a significant unmet need around the world for more affordable versions of injectable insulin products.

“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."

Glargine is one of the three insulin analogs being co-developed by Mylan and Biocon.

Mylan holds exclusive commercialization rights in the US, Canada, Australia, New Zealand, the European Union and European Free Trade Association countries.

Biocon, on the other hand, has exclusive rights for Japan and a few emerging markets; and co-exclusive commercialization rights with Mylan in the remaining parts of the world.