When Drugs Become Biologics: US FDA Guidances Explain 'Transition Provisions'

With two new guidance documents, agency is trying to bring order to the potentially chaotic regulatory process that insulins and other currently approved protein products will face in March 2020; FDA also issues two more Q&A guidance documents on scientific and regulatory considerations for biosimilars.

The concept of order and chaos. Chaotic disorganized colorful paper clips and to order the yellow paper clip

With a raft of new guidance documents, the US FDA is trying to instill order in the potentially chaotic process that some currently approved protein products will face in March 2020, while also clarifying the requirements for bringing new biosimilar products to market.

The agency released four guidance documents Dec. 11 under its Biosimilars Action Plan

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