AbbVie Assumes Two Interchangeable Humira Biosimilars In 2023
Up To Nine Adalimumab Biosimilars to Launch In Key Year
Amid several new and updated draft guidance documents and the potential approach of the first approval, interchangeability continues to be a buzzword in US biosimilars. AbbVie has projected that two Humira (adalimumab) biosimilars will hold the designation when they launch in 2023.
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Boehringer Ingelheim has won a landmark first US interchangeability designation for a biosimilar to Humira, with the firm’s Cyltezo version of adalimumab representing the second ever interchangeable biosimilar approved by the FDA.
Before the month is out, Alvotech hopes to hear back from the US FDA for its AVT02 high-concentration 100mg/ml biosimilar adalimumab candidate. The Icelandic firm, which remains embroiled in litigation with originator AbbVie, has reported top-line results from its key switching study.
Alvotech underlined that it could “save US consumers and taxpayers billions annually,” after hitting a key landmark in its Phase III switching study for its high concentration 100mg/ml biosimilar Humira product.