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.
Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!
GET STARTEDWhat is it?
STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.
What's included?
- Daily reporting and analysis
- The most comprehensive industry coverage from a powerhouse team of reporters
- Subscriber-only newsletters
- Daily newsletters to brief you on the most important industry news of the day
- STAT+ Conversations
- Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
- Exclusive industry events
- Premium access to subscriber-only networking events around the country
- The best reporters in the industry
- The most trusted and well-connected newsroom in the health care industry
- And much more
- Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
About the Author Reprints
