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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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.
US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.
Biosimilar interchangeability is a hot topic in the US, with the first FDA decision on a formal interchangeability designation expected this month. But across the industry, views differ dramatically on the desirability and likely impact of this additional standard to biosimilarity.