Biosimilar Global Reference Standard Intrigues US FDA, But Many Questions Still To Answer

Scientific and legal issues still must be resolved before establishing single reference products for biosimilar development, US FDA official says.

Twin girls are exercising on a lake shore, sprinkling water.

US and European regulators may like the idea of creating a global reference standard for biosimilars, but believe legal and other issues associated with it likely mean the idea is years away from being implemented.

A global reference standard would set one approved version of an innovator product as the basis for a biosimilar's development

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Biosimilars

More from Biosimilars & Generics