European regulator accepts Biocon-Mylan’s application

Mylan and Biocon have declared that the European Medicines Agency (EMA) has accepted for the purpose of review Mylan’s Marketing Authorization Application (MAA) for insulin glargine. Glargine, a long-acting insulin analog is used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes for the control of high blood sugar.

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.

This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan’s and Biocon’s insulin glargine with Lantus. The PK study demonstrated PK and PD bioequivalence of Mylan’s and Biocon’s insulin glargine relative to that of the reference drug Lantus.

According to the Biocon management, the acceptance of the insulin glargine application for review by the EMA is another important milestone in the company’s collaboration with Mylan. This is the third filing from our portfolio comprising biosimilar monoclonal antibodies, insulin analogs and other recombinant proteins to be accepted by EMA in 2016.

The share price of Biocon has increased by 2.03 per cent on bourses in early trades; and is trading at Rs 875.55 on an intraday basis.