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!


What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

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? 🙂

Sign up for our Daily Recap newsletter

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

Privacy Policy