Fol­low­ing CRL, Form 483 re­veals more qual­i­ty is­sues at Alvotech’s pro­duc­tion fa­cil­i­ty in Ice­land

An­oth­er Form 483 for the Ice­landic biosim­i­lar man­u­fac­tur­er Alvotech’s man­u­fac­tur­ing fa­cil­i­ty has shed more light on a re­cent com­plete re­sponse let­ter from the FDA that’s stalling the com­pa­ny’s po­ten­tial new Hu­mi­ra com­peti­tor.

The 12-page re­port, based on the FDA’s in­spec­tion from March, found eight ob­ser­va­tions at Alvotech’s pro­duc­tion site in the Ice­landic cap­i­tal of Reyk­javik — most of them dif­fer­ent from last year’s in­spec­tion. This re­port stat­ed that Alvotech’s qual­i­ty unit was not ef­fec­tive in car­ry­ing out du­ties to en­sure that drug prod­ucts had good man­u­fac­tur­ing prac­tices.

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Life Sciences Senior Associate

General Catalyst

San Francisco, CA, USA