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FDA Promises Interchangeability For Alvotech’s 100mg/ml Humira Rival – If It Passes Inspection

April 2023 Approval For AVT02 Adalimumab Biosimilar Hinges On Facility Nod

 
• By Dave Wallace

Alvotech has been bolstered by a US FDA confirmation that its AVT02 adalimumab candidate can be approved as an interchangeable biosimilar based on the data provided in its filing – but first, the Icelandic firm must pass an upcoming facility inspection.

13 April Calendar
The FDA goal date for AVT02 is 13 April 2023 • Source: Shutterstock

Alvotech’s hopes of obtaining US approval for an interchangeable high-concentration adalimumab biosimilar in April hinge entirely on a successful US Food and Drug Administration facility reinspection, expected by March, the company has confirmed, revealing that the FDA had now provided assurances that the AVT02 candidate could be approved as interchangeable based on data provided in the firm’s US filing.

“The US FDA has confirmed that the goal date for an approval decision on Alvotech’s license application for AVT02 is 13 April 2023,” the company disclosed in an update on...

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