Interchangeable Biosimilars: Insulin Likely First But Humira May Be More Important Precedent
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.
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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.
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.
Senate negotiators opt to delay but not withdraw the pharma-backed rebate rule and target a relatively small reform aimed at allowing Medicare Part B to recoup the cost of leftover physician-administered drugs