1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Biosimilars

US FDA Gets Earful On Biologic ‘Umbrella’ Exclusivity, Patent Listings, Biosimilar Bridging Study Waivers

 
• By Sue Sutter

BIO and PhRMA want an exclusivity policy that protects subsequent changes to innovator biologics and oppose patent listings in the Purple Book; AAM says agency should waive unnecessary clinical bridging studies based on information provided under confidentiality agreements with foreign regulators.

Man with hearing problem on grey background, closeup
US FDA heard plenty of feedback from industry trade groups on issues involving biosimilar competition and product innovation.

Marketing exclusivity, patent listings, and biosimilar clinical bridging study waivers are key areas of concern for biopharmaceutical industry trade associations when it comes to potential actions the US FDA might take to promote biological competition and innovation.

In comments submitted to the public docket related to FDA’s Sept

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