Alvotech’s Reyk­javik man­u­fac­tur­ing dol­drums con­tin­ue with CRL for Ste­lara biosim­i­lar

Alvotech and part­ner Te­va’s Ste­lara biosim­i­lar has been re­ject­ed by the FDA due to man­u­fac­tur­ing con­cerns, mark­ing the fourth reg­u­la­to­ry set­back for the duo dat­ing back to 2022 re­lat­ed to a prob­lem­at­ic Ice­land fa­cil­i­ty.

The agency is­sued a CRL to the BLA for the Ste­lara biosim­i­lar, dubbed AVT04, cit­ing “cer­tain de­fi­cien­cies” at its Reyk­javik site in Ice­land dur­ing a March in­spec­tion. Alvotech did not pro­vide de­tails but said the con­cerns were “as ex­pect­ed,” adding it would re­sub­mit the ap­pli­ca­tion short­ly.

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