Alvotech resubmits its interchangeable Humira biosimilar as AbbVie clings to brand dominance

Bil­lion­aire Alvotech CEO Róbert Wess­man told in­vestors on Thurs­day that the com­pa­ny has re­sub­mit­ted its Hu­mi­ra in­ter­change­able biosim­i­lar ap­pli­ca­tion to the FDA af­ter re­ceiv­ing a com­plete re­sponse let­ter due to man­u­fac­tur­ing is­sues last April.

While he did not dis­close a new PDU­FA date yet, he sound­ed a pos­i­tive tone on im­prov­ing the man­u­fac­tur­ing de­fi­cien­cies at a Reyk­javík plant that led to the sec­ond CRL for the po­ten­tial in­ter­change­able biosim­i­lar, al­so known as AVT02.

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