Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations
The US FDA has slapped Biocon with a dozen observations over three units at its insulin manufacturing facility in Malaysia, but the Indian biotech firm says the problems can be remedied quickly and that US launch plans are on track for its insulin product glargine challenging French drug-maker Sanofi’s multi-billion-dollar Lantus.
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Biocon has run into fresh trouble with the US Food and Drug Administration after receiving a complete response letter on its application for insulin glargine, a proposed rival to Sanofi’s top-selling Lantus biologic.
Accord and Aspire have knocked down a patent barrier to bringing bimatoprost 0.1mg/ml to the UK market by convincing a Patent Court judge that the claimed formulation was obvious.
Biocon rang in a strong fourth quarter amid signs of a build-up in efforts towards supporting the “independent functioning” of its biosimilars business under subsidiary Biocon Biologics.