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Teva Confident On US Adalimumab Filing Amid Alvotech Advantages

‘Out Of Maybe Seven Competitors, Three, Maybe Four, Will Really Get Going’

 
• By Dean Rudge

A delay in FDA approval for partner Alvotech’s proposed high-concentration biosimilar version of Humira has not concerned Teva, especially after the product was approved by the EMA at the end of last year. There “shouldn’t really be any challenges here,” management says.

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'Sometime people launch at risk,' Teva says • Source: Alamy

Teva remains confident of securing US Food and Drug Administration approval for the proposed high-concentration biosimilar Humira (adalimumab) product that it has in-licensed from Alvotech, amid a recent deferral on the Icelandic firm’s application until facility assessments can be completed.

Meanwhile, as biosimilar sponsors continue the race to secure competitive advantages for a market that is set to feature a multitude of players, “I think the ones with the latest

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