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 user fee goal 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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