1. Pink Sheet
  3. >>Biosimilars

Biosimilars: Next User Fee Cycle Will Be Judged On US FDA's Approvals, Rep. Burgess Says

 
• By Derrick Gingery

Chair of the House Energy and Commerce Health Subcommittee expects BsUFA II also to be judged on FDA's review process predictability.

Human antibody

The US FDA should expect enhanced congressional pressure to get more biosimilars on the market in the coming years. Rep. Michael Burgess, R-Texas, who chairs the House Energy and Commerce Health Subcommittee seems troubled by the fact that there have been only four approvals during the first five years of the biosimilar user fee program.

Burgess said March 15 during a biosimilars policy briefing sponsored by The Atlantic that FDA will be judged during the...

Welcome to Pink Sheet

Create an account to read this article

Already a subscriber?

More from Biosimilars

More from Biosimilars & Generics

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).

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.