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Mexico clears Biocon's 'biocomparable' insulin glargine

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Executive Summary

Mexico has approved Biocon's insulin glargine, the first such product cleared under the Latin American nation's biocomparable approvals pathway defined in 2012. Biocon said that its insulin glargine (Galactus) has been approved by Mexico's Cofepris, through the Indian firm's partner PiSA Farmaceutica. While details on Galactus' pricing were not immediately available, the partners hope to facilitate a lowering of per capita expenditure on diabetes with the use of their "cost effective" insulin glargine. Mexico is estimated to have more than nine million cases of diabetes, with per capita expenditure on the disease as high as $892.5. The market for insulin glargine in Mexico is said to be in excess of $40m, with the overall insulins market estimated at around $150m. The total annual cost of managing diabetes and its complications in Mexico in 2000 was estimated at more than $15bn, of which around $765m represented direct medication costs, data published in the 2003 bulletin of the WHO said.

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