Biocon’s efforts to win US approval to market its key diabetes challenger to French drugmaker Sanofi’s blockbuster Lantus (insulin glargine) has hit another stumbling block, with the US Food and Drug Administration saying it will not accept the insulin glargine application, filed by partner Mylan, in its current form.
Biocon insisted in a statement it was confident that the latest development would not affect the timing of the US launch for the insulin glargine biosimilar
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