Biocon’s insulin biosimilar rejected yet again by FDA after manufacturing deficiencies

The FDA has re­ject­ed Bio­con Bi­o­log­ics’ biosim­i­lar ver­sion of in­sulin as­part due to is­sues iden­ti­fied at its Malaysia fa­cil­i­ty af­ter an Aug. 2022 in­spec­tion.

The pre-ap­proval in­spec­tion found prob­lems at the fa­cil­i­ty, al­though there were “no out­stand­ing sci­en­tif­ic is­sues with the prod­uct,” Bio­con re­vealed in an Oct. 7 press re­lease.

In­sulin as­part is a fast-act­ing ver­sion of in­sulin used to treat type 1 and type 2 di­a­betes. It is mar­ket­ed un­der brand names such as No­voLog (by No­vo Nordisk) and Tru­rapi (by Sanofi). The price of No­vo’s ver­sion will face gov­ern­ment ne­go­ti­a­tions in 2026.

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