A federal appeals court ruled on Tuesday that biosimilar makers must always notify their brand-name rivals six months before launching their lower-cost versions of expensive biologic medicines. The decision may have a significant impact on near-term 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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