Alvotech Reveals Action Date For Interchangeable Adalimumab BLA

FDA Has Accepted AVT02 BLA For Review Including New Data

While awaiting news from the FDA for its biosimilar application referencing the higher-concentration formulation of Humira, Alvotech has announced that the FDA has accepted its BLA supporting interchangeability for the AVT02 candidate.

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Alvotech: we would have exclusivity for the higher concentration • Source: ValentinT / Alamy Stock Photo

The potential prize of pharmacy-level substitution as well as a year of first interchangeable biosimilar exclusivity for Alvotech’s proposed AVT02 higher-strength 100mg/ml adalimumab biosimilar has moved a step closer.

The US Food and Drug Administration has accepted for review the company’s biologics licensing application for AVT02 that includes new data supporting

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