Alvotech Bullish As Facility Deficiencies Hold Up Humira Biosimilar Again
AVT02 Higher-Concentration Adalimumab Formulation Previously Delayed
Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.
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Alvotech has secured a US FDA reinspection of its Reykjavik plant in March, ahead of the agency’s April goal date for action on the firm’s pending application for a high-concentration, interchangeable adalimumab biosimilar rival to Humira.
The advent of US biosimilar competition to Humira in 2023 represents the largest ever loss-of-exclusivity opportunity for the off-patent industry, with the first adalimumab rival expected to hit the US market at the end of this month. But with a host of other biosimilars expected to launch throughout the year, how will competition play out in the long term?
The advent of biosimilar competition to Humira in the US in 2023 represents the largest loss-of-exclusivity opportunity ever for the off-patent industry. But with a host of biosimilar sponsors awaiting launches throughout the year, it remains to be seen how competition will play out.