Alvotech Awaits Date With Destiny, With FDA Inspection To Begin On 6 March
Icelandic Firm’s Reykjavik Facility Must Pass FDA Inspection To Unlock Biosimilars
As Alvotech reported its first annual financial results, the company spoke of the imminent FDA inspection at its Icelandic manufacturing facility. An earlier inspection has so far put the kibosh on US approval for Alvotech’s proposed Humira (adalimumab) biosimilar.
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Teva has spoken of its US biosimilars alliance with Alvotech, in the wake of several major setbacks for the companies’ plans to launch a biosimilar to AbbVie’s Humira (adalimumab) juggernaut on 1 July.
Six months after replacing its chief quality officer, biosimilars specialist Alvotech has again appointed a new head of quality, in the wake of the latest US FDA knockback for its AVT02 proposed adalimumab biosimilar rival to Humira.
Alvotech has received a further complete response letter from the US FDA relating to its AVT02 proposed adalimumab biosimilar rival to Humira. The latest BsUFA goal date disclosed for the product is now just a few days ahead of a potential US launch.