New blow for Alvotech and Teva's Humira biosimilar

Deficiencies identified by the US Food and Drug Administration (FDA) at Icelandic biosimilar firm Alvotech’s (Nasdaq: ALVO) Reykjavik facility have resulted in a second complete response letter (CRL) for AVT02, its copy of Humira (adalimumab).

The company’s previous Biologics License Application (BLA) for AVT02 was also rejected by the FDA because of issues at the manufacturing plant.

Now Alvotech, which is partnering with Teva Pharmaceutical Industries (NYSE: TEVA) on AVT02, intends to resubmit a BLA to the FDA, which would trigger a six-month review period and a new Biosimilar User Fee Act date.