Te­va and Alvotech strike deal for 'in­creased in­volve­men­t' at Alvotech's trou­bled Ice­land site

Te­va is tak­ing Alvotech’s man­u­fac­tur­ing trou­bles in­to its own hands af­ter de­fi­cien­cies at an Ice­landic fa­cil­i­ty led to an­oth­er re­jec­tion for the part­ners’ Hu­mi­ra biosim­i­lar last month.

The ex­pand­ed part­ner­ship an­nounced Mon­day in­cludes “in­creased in­volve­ment by Te­va re­gard­ing man­u­fac­tur­ing and qual­i­ty at Alvotech’s man­u­fac­tur­ing fa­cil­i­ty,” the com­pa­nies said in a press re­lease.

The FDA turned down two sep­a­rate bi­o­log­ics li­cense ap­pli­ca­tions for the com­pa­nies’ Hu­mi­ra biosim­i­lar can­di­date AVT02 this year. A Te­va spokesper­son con­firmed to End­points News that those re­jec­tions were be­hind the gener­ics gi­ant’s greater in­volve­ment. In June, reg­u­la­tors not­ed “cer­tain de­fi­cien­cies” at Alvotech’s Reyk­javik fa­cil­i­ty in a com­plete re­sponse let­ter for a BLA sup­port­ing in­ter­change­abil­i­ty, ac­cord­ing to Alvotech. The com­pa­ny gave a sim­i­lar ex­pla­na­tion up­on the drug’s pri­or re­jec­tion in April for a sep­a­rate BLA that did not sup­port in­ter­change­abil­i­ty. The biosim­i­lar can­di­date was al­so re­ject­ed last year.

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