Broad alliance queries FDA’s suffixes stance

The US Food and Drug Administration (FDA) should clarify its current thinking on whether biosimilars and original biologics should addafour-letter meaningless suffix to the non-proprietary names of their products, according to a broad coalition covering biosimilar developers, health insurers, pharmacy benefit managers (PBMs), retailers, doctors, pharmacists and consumers. “Does this still represent the agency’s current thinking?” the alliance queries in a submission to a docket on facilitating competition and innovation in the biological products marketplace.

The US Food and Drug Administration (FDA) should clarify its current thinking on whether biosimilars and original biologics should addafour-letter meaningless suffix to the non-proprietary names of their products, according to a broad coalition covering biosimilar developers, health insurers, pharmacy benefit managers (PBMs), retailers, doctors, pharmacists and consumers. “Does this still represent the agency’s current thinking?” the alliance queries in a submission to a docket on facilitating competition and innovation in the biological products marketplace.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

More from Policy & Regulation