Biopharma major Biocon and Mylan NV said the European regulator has accepted their review application to market insulin glargine in Europe.
The insulin glargine is used to treat adults with Type 2 diabetes and adults and paediatric patients with Type 1 diabetes.
“The European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorisation Application for insulin glargine,” Biocon said in a regulatory filing to the BSE.
This is their 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 and confirmatory efficacy and safety global clinical trial in Type 2 diabetics patients.
“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,” said Rajiv Malik, President, Mylan.
Biocon and Mylan are exclusive partners for developing broad portfolio of biosimilars and insulin analogs. Glargine is one of the three insulin analogs being co-developed by Mylan and Biocon.
