The old adage “haste makes waste” usually makes sense. The Food and Drug Administration is following that adage in its thorough and thoughtful approach to building the ground rules for a successful biosimilars market in the United States.

Some in the pharmaceutical industry are calling for a faster solution to bringing biosimilars into the market. I think that would be a mistake. It could lead to one or more products being approved and broadly used that are not actually equivalent or worse — they could have increased immunogenicity, as was seen early in the European Union with the development of biosimilars to human growth hormone and erythropoietin.

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


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.

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

Privacy Policy