European regulator EMA to review Biocon-Mylan’s version of insulin glargine
Biocon said the application includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics and confirmatory efficacy/safety global clinical trial in type 2 diabetes patients comparing Mylan and Biocon’s insulin glargine with Lantus
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Hyderabad: Drug makers Mylan NV and Biocon Ltd on Thursday said the European Medicines Agency (EMA) has agreed to review Mylan’s application seeking permission to bring biosimilar version of insulin glargine to Europe.
Insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.
A biosimilar is a complex biological product that follows a different approval pathway compared to chemical drugs.
Biocon said the 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 bioequivalence of Mylan’s and Biocon’s insulin glargine relative to that of the reference drug Lantus,” Biocon said in a statement.
Biocon has indicated earlier that it takes roughly 12-15 months for review and approval by EMA.
“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,” said Rajiv Malik, president of Mylan.
“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,” Malik said.
“The acceptance of the insulin glargine application for review by the EMA is another important milestone in Biocon’s collaboration with Mylan,” said Arun Chandavarkar, chief executive officer and joint managing director of Biocon.
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.
In the second quarter, EMA agreed to review Biocon’s applications seeking permission for marketing authorization of pegfilgrastim and trastuzumab.
Pegfilgrastim is used to stimulate the level of neutrophils, a type of white blood cells, in cancer patients undergoing chemotherapy, while trastuzumab is used in the treatment of HER2-positive metastatic breast cancer.
This is the first filing in a developed market that incorporates product validated at our company’s new insulins facility in Malaysia and takes us a step closer to our mission of improving access to more affordable insulins globally.
Biocon has indicated it will be filing at least four biosimilar applications for review in Europe and the US.
The announcement came after market hours.
Biocon’s shares declined 1.05% to close at Rs900 on BSE, the benchmark Sensex declined 0.35% to end at 27,430.28 points.