In an unexpected move, the Food and Drug Administration has decided that biosimilar medicines should have distinct naming features from brand-name biologics in order to bolster patient safety, a step that has infuriated biosimilar manufacturers.

Specifically, the FDA issued a draft guidance that says biosimilars should have four-letter suffixes added to their names, but brand-name biologics that are already licensed – and do not currently have a suffix – will not need such a feature. In doing so, the agency is trying to settle a long-running debate over the best approach for naming biosimilars, which has vexed regulators and divided drug makers over patient safety and the potential for big profits.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What 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
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • 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.

Leave a Comment

Please enter your name.
Please enter a comment.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy