1. Pink Sheet
  2. >>Biosimilars & Generics

BsUFA III: Reauthorization Process Begins With US FDA Considering Staffing, Uptake Issues

 
• By Derrick Gingery

Biosimilar availability may not be in the its purview, but the FDA still is thinking about ways to help industry deal with the issue and support sector growth.

FDA entrance sign 2016
The virtual BsUFA III kick-off meeting is scheduled for 9 a.m. to 12:30 p.m. on 19 November.

As industry and the Food and Drug Administration prepare to begin discussions on regulatory structure that will guide the second decade of biosimilars in the US, agency officials appear willing to test the limits of FDA’s purview and push into product availability issues as part of an effort to encourage more sector growth.

Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), said that “important factors affecting availability of...

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
Start Free Trial

Already a subscriber?

More from Biosimilars

More from Biosimilars & Generics

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).