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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