WASHINGTON — The FDA on Friday spelled out exactly what kind of studies biosimilar drug makers must conduct in order to be considered “interchangeable” with a biologic drug the way a generic functions for a normal medicine.

It’s the agency’s final word on a controversial and long-running fight over how it will define those rules for the pricey category of biologic drugs, the complex drugs made from living organisms used to treat conditions like cancer, and their copycat biosimilars.

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

GET STARTED

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.

  • what is largely not understood, even by prescribers, is that each manufactured lot of any biologic is not exactly the same as another. There is unavoidable variability due to the process involved with manufacturing a biologic. Just the requirement for a biosimilar to do studies signals that they may somehow be significantly different from the originator biologic, which is both not true and also plays right into the narrative originator biologics have been telling for years in order to protect their lucrative business. It has worked (so far) and FDA is complicit. Meanwhile patients and taxpayers are having their pockets picked.

    • just to clarify the intent of the first sentence above, each lot of an originator biologic will inevitably be different from the prior one. If biosimilars need to do interchangability studies, then you can also argue that originators need to do the same with different lots. It’s silly.

Sign up for our Daily Recap newsletter

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

Privacy Policy