A federal appeals court ruled on Tuesday that biosimilar makers must always notify their brand-name rivals six months before launching expensive biologic medicines. The decision is likely to have a significant impact on health care costs, because it will effectively delay competition for these pricey drugs.
Although the same court has previously decided this overarching issue, the latest decision actually turned on a related interpretation of the same federal law that governs the complex procedures biosimilar makers must follow as they seek to market their lower-cost medicines.
At issue is whether a biosimilar company must provide a brand-name rival with 180-day notice before launching its products, a requirement in the Biologics Price Competition and Innovation Act.
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