An aspiring biosimilar manufacturer is employing a citizen’s petition in a novel way in hopes of setting regulatory approval standards. In a May 3 letter, Apotex asked the Food and Drug Administration to set a specific requirement for other biosimilar companies that, depending upon what the agency decides, may serve as a barrier to regulatory approval of their treatments.

Here’s the back story: Apotex is seeking FDA approval to sell a biosimilar version of Neulasta, a drug sold by Amgen that notched $3.9 billion in sales in the US last year and helps cancer patients on chemotherapy fight infections. However, an erstwhile rival called Coherus last year released a statement indicating its own application for a biosimilar version evaluated the clinical effect only in healthy patients.

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.

  • @Ed

    A trial in healthy patients? REALLY? What are the inclusion/exclusion criteria to NOT end with an empty cohort? 🙂

Your daily dose of news in health and medicine

Privacy Policy