T

he Food and Drug Administration lags behind its European counterpart when it comes to approving biosimilars — but a top agency official insisted Tuesday that the agency is not as far behind as some critics suggest.

Leah Christl, the associate director for therapeutic biologics at the FDA’s Center for Drug Evaluation and Research, pushed back on an oft-cited statistic that shows the European Medicines Agency has so far approved more than 40 biosimilars, drugs that are almost identical to biologics, compared to just nine approved in the U.S. by the FDA.

Unlock this article by subscribing to STAT Plus. Try it FREE for 30 days!

SUBSCRIBE TODAY

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.

Sign up for our Morning Rounds newsletter

Your daily dose of what’s new in health and medicine.

Privacy Policy