Boehringer Makes Case For Interchangeable Adalimumab Biosimilar
Voltaire-X Switching Study Concludes Similar Clinical Outcomes
Boehringer Ingelheim, which is looking to be among the limited players to offer an interchangeable biosimilar in the US, has reported positive switching data from the company’s “first-of-its-kind” Phase IIIb Voltaire-X study.
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As Boehringer Ingelheim’s Cyltezo has become the second-ever interchangeable biosimilar approved by the US FDA – as well as the first monoclonal antibody to garner the designation and offering the first published data from a switching trial to support interchangeability – the debate around the potential impact for interchangeable products in the keenly-watched adalimumab space and beyond continues to grow.
First Interchangeable Humira Biosimilar Approved In US
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.
Alvotech Champions Switching Data As Clock Ticks On Adalimumab Filing
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.