Sanofi Settlement With Lilly Paves The Way For Biosimilar Lantus
This article was originally published in The Pink Sheet Daily
Eli Lilly’s copycat version of Sanofi’s blockbuster insulin Lantus could reach the market in the U.S. in December 2016 following a settlement agreement with Sanofi.
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Thirty-month stay resulting from Sanofi’s patent lawsuit expires on 18 March 2020, two days before Mylan’s application must receive final approval to avoid getting caught in the transition of insulins from drug to biologic regulation. Pre-approval inspection of Biocon’s manufacturing facility resulted in 12 ‘largely procedural’ observations, company says.
Researchers analyzed usage rates, market share and reimbursement information for the long-acting insulins Lantus and Basaglar to determine the impact from the launch of Lilly’s long-acting Basaglar.
Sales of the insulin glargine product in its first full year on the market were strong at $432.1m, but Lilly said it is offering steep rebates in exchange for market access and it's not clear that the growth is sustainable if more copies enter the market.