European regulator to review Biocon-Mylan’s insulin
Bengaluru, Nov 3 (IANS) The European Medicines Agency (EMA) has accepted to review insulin Glargine co-developed by India’s leading biotech firm Biocon and American drug maker Mylan to control of high blood sugar, said the city-based company on Thursday.
“The EMA has accepted for review Mylan’s marketing authorisation application for insulin Glargine, used to treat adults with type 2 diabetes and adults and children with type 1 diabetes for the control of high blood sugar,” said Biocon in a statement here.
Looking forward to offering another insulin treatment option for diabetic patients, Biocon said the filing includes analytical, functional and pre-clinical data.
“We have also submitted results from the pharmacokinetics and confirmatory efficacy global clinical trial in type 2 diabetes patients comparing our insulin with that of Lantus,” said the joint statement quoting both the drug makers.
Noting that 15 per cent of the world’s pharmaceutical spend would be on diabetes medicines by 2020, Mylan President Rajiv Malik said there was also a significant unmet need the world over for affordable versions of injectable insulin products.
“We look forward to helping serve this patient population, building on our strength in oral diabetic drugs, by bringing this product to the European market and other markets the world over upon approval,” he said in the statement.
Terming EMA’s acceptance of their application for review as a milestone, Biocon Chief Executive Arun Chandavarkar said it was the third filing from the company’s portfolio comprising biosimilar monoclonal antibodies, insulin analogs and other recombinant proteins this year.
“This is the first filing in a developed market that incorporates product validated at our Malaysia facility and takes us a step closer to our mission of improving access to more affordable insulins globally,” he added.