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

 
• By Dean Rudge

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.

• Source: Shutterstock

The coming Monday, 6 March, is a key date in the diary for Alvotech – potentially, a watershed moment for the firm that could decide whether it is able to join in a timely fashion the glut of second wave adalimumab biosimilars set to launch in the US later this year.

On that day, the US Food and Drug Administration will begin its re-inspection of the firm’s manufacturing facility in Reykjavik, Iceland, a prerequisite for the US approval of its

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